SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACT … · 2017-10-02 · 419 SUBCHAPTER C—FEDERAL...

419

SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS

PART 1500—HAZARDOUS SUB-STANCES AND ARTICLES; ADMIN-ISTRATION AND ENFORCEMENT REGULATIONS

Sec. 1500.1 Scope of subchapter. 1500.2 Authority. 1500.3 Definitions. 1500.4 Human experience with hazardous

substances. 1500.5 Hazardous mixtures. 1500.12 Products declared to be hazardous

substances under section 3(a) of the act. 1500.13 Listing of ‘‘strong sensitizer’’ sub-

stances. 1500.14 Products requiring special labeling

under section 3(b) of the act. 1500.15 Labeling of fire extinguishers. 1500.17 Banned hazardous substances. 1500.18 Banned toys and other banned arti-

cles intended for use by children. 1500.19 Misbranded toys and other articles

intended for use by children. 1500.20 Labeling requirement for advertising

toys and games. 1500.40 Method of testing toxic substances. 1500.41 Method of testing primary irritant

substances. 1500.42 Test for eye irritants. 1500.43 Method of test for flashpoint of vola-

tile flammable materials by Tagliabue open-cup apparatus.

1500.43a Method of test for flashpoint of volatile flammable materials.

1500.44 Method for determining extremely flammable and flammable solids.

1500.45 Method for determining extremely flammable and flammable contents of self-pressurized containers.

1500.46 Method for determining flashpoint of extremely flammable contents of self- pressurized containers.

1500.47 Method for determining the sound pressure level produced by toy caps.

1500.48 Technical requirements for deter-mining a sharp point in toys and other articles intended for use by children under 8 years of age.

1500.49 Technical requirements for deter-mining a sharp metal or glass edge in toys and other articles intended for use by children under 8 years of age.

1500.50 Test methods for simulating use and abuse of toys and other articles intended for use by children.

1500.51 Test methods for simulating use and abuse of toys and other articles intended for use by children 18 months of age or less.

1500.52 Test methods for simulating use and abuse of toys and other articles intended for use by children over 18 but not over 36 months of age.

1500.53 Test methods for simulating use and abuse of toys and other articles intended for use by children over 36 but not over 96 months of age.

1500.81 Exemptions for food, drugs, cos-metics, and fuels.

1500.82 Exemption from full labeling and other requirements.

1500.83 Exemptions for small packages, minor hazards, and special cir-cumstances.

1500.85 Exemptions from classification as banned hazardous substances.

1500.86 Exemptions from classification as a banned toy or other banned article for use by children.

1500.87 Children’s products containing lead: inaccessible component parts.

1500.88 Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain elec-tronic devices.

1500.89 Procedures and requirements for de-terminations regarding lead content of materials or products under section 101(a) of the Consumer Product Safety Improvement Act.

1500.90 Procedures and requirements for ex-clusions from lead limits under section 101(b) of the Consumer Product Safety Improvement Act.

1500.91 Determinations regarding lead con-tent for certain materials or products under section 101 of the Consumer Prod-uct Safety Improvement Act.

1500.121 Labeling requirements; prominence, placement, and conspicuousness.

1500.122 Deceptive use of disclaimers. 1500.123 Condensation of label information. 1500.125 Labeling requirements for accom-

panying literature. 1500.126 Substances determined to be ‘‘spe-

cial hazards.’’ 1500.127 Substances with multiple hazards. 1500.128 Label comment. 1500.129 Substances named in the Federal

Caustic Poison Act. 1500.130 Self-pressurized containers: label-

ing. 1500.133 Extremely flammable contact adhe-

sives; labeling. 1500.134 Policy on first aid labeling for sa-

line emesis. 1500.135 Summary of guidelines for deter-

mining chronic toxicity. 1500.210 Responsibility. 1500.211 Guaranty.

VerDate Nov<24>2008 15:16 Feb 23, 2010 Jkt 220052 PO 00000 Frm 00429 Fmt 8010 Sfmt 8010 Q:\16\16V2 ofr150 PsN: PC150

420

16 CFR Ch. II (1–1–10 Edition) § 1500.1

1500.212 Definition of guaranty; suggested forms.

1500.213 Presentation of views under section 7 of the act.

1500.214 Examinations and investigations; samples.

1500.230 Guidance for lead (Pb) in consumer products.

1500.231 Guidance for hazardous liquid chemicals in children’s products.

IMPORTS

1500.265 Imports; definitions. 1500.266 Notice of sampling. 1500.267 Payment for samples. 1500.268 Hearing. 1500.269 Application for authorization. 1500.270 Granting of authorization. 1500.271 Bonds. 1500.272 Costs chargeable in connection with

relabeling and reconditioning inadmis-sible imports.

AUTHORITY: 15 U.S.C. 1261–1278, 122 Stat. 3016.

SOURCE: 38 FR 27012, Sept. 27, 1973, unless otherwise noted.

§ 1500.1 Scope of subchapter. Set forth in this subchapter C are the

regulations of the Consumer Product Safety Commission issued pursuant to and for the implementation of the Fed-eral Hazardous Substances Act as amended (see § 1500.3(a)(1)).

§ 1500.2 Authority. Authority under the Federal Haz-

ardous Substances Act is vested in the Consumer Product Safety Commission by section 30(a) of the Consumer Prod-uct Safety Act (15 U.S.C. 2079(a)).

§ 1500.3 Definitions. (a) Certain terms used in this part. As

used in this part: (1) Act means the Federal Hazardous

Substances Act (Pub. L. 86–613, 74 Stat. 372–81 (15 U.S.C. 1261–74)) as amended by:

(i) The Child Protection Act of 1966 (Pub. L. 89–756, 80 Stat. 1303–05).

(ii) The Child Protection and Toy Safety Act of 1969 (Pub. L. 91–113, 83 Stat. 187–90).

(iii) The Poison Prevention Pack-aging Act of 1970 (Pub. L. 91–601, 84 Stat. 1670–74).

(2) Commission means the Consumer Product Safety Commission estab-lished May 14, 1973, pursuant to provi-sions of the Consumer Product Safety

Act (Pub. L. 92–573, 86 Stat. 1207–33 (15 U.S.C. 2051–81)).

(b) Statutory definitions. Except for the definitions given in section 2 (c) and (d) of the act, which are obsolete, the definitions set forth in section 2 of the act are applicable to this part and are repeated for convenience as follows (some of these statutory definitions are interpreted, supplemented, or provided with alternatives in paragraph (c) of this section):

(1) Territory means any territory or possession of the United States, includ-ing the District of Columbia and the Commonwealth of Puerto Rico but ex-cluding the Canal Zone.

(2) Interstate commerce means (i) com-merce between any State or territory and any place outside thereof and (ii) commerce within the District of Co-lumbia or within any territory not or-ganized with a legislative body.

(3) Person includes an individual, partnership, corporation, and associa-tion.

(4)(i) Hazardous substance means: (A) Any substance or mixture of sub-

stances which is toxic, corrosive, an ir-ritant, a strong sensitizer, flammable or combustible, or generates pressure through decomposition, heat, or other means, if such substance or mixture of substances may cause substantial per-sonal injury or substantial illness dur-ing or as a proximate result of any cus-tomary or reasonably foreseeable han-dling or use, including reasonably fore-seeable ingestion by children.

(B) Any substance which the Com-mission by regulation finds, pursuant to the provisions of section 3(a) of the act, meet the requirements of section 2(f)(1)(A) of the act (restated in (A) above).

(C) Any radioactive substance if, with respect to such substance as used in a particular class of article or as packaged, the Commission determines by regulation that the substance is suf-ficiently hazardous to require labeling in accordance with the act in order to protect the public health.

(D) Any toy or other article intended for use by children which the Commis-sion by regulation determines, in ac-cordance with section 3(e) of the act, presents an electrical, mechanical, or thermal hazard.


421

Consumer Product Safety Commission § 1500.3

(ii) Hazardous substance shall not apply to pesticides subject to the Fed-eral Insecticide, Fungicide, and Rodenticide Act, to foods, drugs, and cosmetics subject to the Federal Food, Drug, and Cosmetic Act, nor to sub-stances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration sys-tem of a house. ‘‘Hazardous substance’’ shall apply, however, to any article which is not itself a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act but which is a hazardous substance within the meaning of section 2(f)(1) of the Federal Hazardous Substances Act (re-stated in paragraph (b)(4)(i) of this sec-tion) by reason of bearing or con-taining such a pesticide.

(iii) Hazardous substance shall not in-clude any source material, special nu-clear material, or byproduct material as defined in the Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission.

(5) Toxic shall apply to any substance (other than a radioactive substance) which has the capacity to produce per-sonal injury or illness to man through ingestion, inhalation, or absorption through any body surface.

(6)(i) Highly toxic means any sub-stance which falls within any of the following categories:

(A) Produces death within 14 days in half or more than half of a group of 10 or more laboratory white rats each weighing between 200 and 300 grams, at a single dose of 50 milligrams or less per kilogram of body weight, when orally administered; or

(B) Produces death within 14 days in half or more than half of a group of 10 or more laboratory white rats each weighing between 200 and 300 grams, when inhaled continuously for a period of 1 hour or less at an atmospheric con-centration of 200 parts per million by volume or less of gas or vapor or 2 mil-ligrams per liter by volume or less of mist or dust, provided such concentra-tion is likely to be encountered by man when the substance is used in any rea-sonably foreseeable manner; or

(C) Produces death within 14 days in half or more than half of a group of 10 or more rabbits tested in a dosage of

200 milligrams or less per kilogram of body weight, when administered by continuous contact with the bare skin for 24 hours or less.

(ii) If the Commission finds that available data on human experience with any substance indicate results dif-ferent from those obtained on animals in the dosages and concentrations spec-ified in paragraph (b)(6)(i) of this sec-tion, the human data shall take prece-dence.

(7) Corrosive means any substance which in contact with living tissue will cause destruction of tissue by chemical action, but shall not refer to action on inanimate surfaces.

(8) Irritant means any substance not corrosive within the meaning of sec-tion 2(i) of the act (restated in para-graph (b)(7) of this section) which on immediate, prolonged, or repeated con-tact with normal living tissue will in-duce a local inflammatory reaction.

(9) Strong sensitizer means a substance which will cause on normal living tis-sue through an allergic or photodynamic process a hyper-sensitivity which becomes evident on reapplication of the same substance and which is designated as such by the Commission. Before designating any substance as a strong sensitizer, the Commission, upon consideration of the frequency of occurrence and severity of the reaction, shall find that the sub-stance has a significant potential for causing hypersensitivity.

(10) The terms extremely flammable, flammable, and combustible as they apply to any substances, liquid, solid, or the contents of any self-pressurized container, are defined by regulations issued by the Commission and pub-lished at § 1500.3(c)(6).

(11) Radioactive substance means a substance which emits ionizing radi-ation.

(12) Label means a display of written, printed, or graphic matter upon the immediate container of any substance or, in the cases of an article which is unpackaged or is not packaged in an immediate container intended or suit-able for delivery to the ultimate con-sumer, a display of such matter di-rectly upon the article involved or upon a tag or other suitable material affixed thereto. A requirement made by


422

16 CFR Ch. II (1–1–10 Edition) § 1500.3

or under authority of the act that any word, statement, or other information appear on the label shall not be consid-ered to be complied with unless such word, statement, or other information also appears (i) on the outside con-tainer or wrapper, if any there be, un-less it is easily legible through the out-side container or wrapper and (ii) on all accompanying literature where there are directions for use, written or other-wise.

(13) Immediate container does not in-clude package liners.

(14) Misbranded hazardous substance means a hazardous substance (includ-ing a toy, or other article intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is en-trusted) intended, or packaged in a form suitable, for use in the household or by children, if the packaging or la-beling of such substance is in violation of an applicable regulation issued pur-suant to section 3 or 4 of the Poison Prevention Packaging Act of 1970 or if such substance, except as otherwise provided by or pursuant to section 3 of the act (Federal Hazardous Substances Act), fails to bear a label:

(i) Which states conspicuously: (A) The name and place of business of

the manufacturer, packer, distributor, or seller;

(B) The common or usual name or the chemical name (if there be no com-mon or usual name) of the hazardous substance or of each component which contributes substantially to its hazard, unless the Commission by regulation permits or requires the use of a recog-nized generic name;

(C) The signal word ‘‘DANGER’’ on substances which are extremely flam-mable, corrosive, or highly toxic;

(D) The signal word ‘‘WARNING’’ or ‘‘CAUTION’’ on all other hazardous substances;

(E) An affirmative statement of the principal hazard or hazards, such as ‘‘Flammable,’’ ‘‘Combustible,’’ ‘‘Vapor Harmful,’’ ‘‘Causes Burns,’’ ‘‘Absorbed Through Skin,’’ or similar wording de-scriptive of the hazard;

(F) Precautionary measures describ-ing the action to be followed or avoid-

ed, except when modified by regulation of the Commission pursuant to section 3 of the act;

(G) Instruction, when necessary or appropriate, for first-aid treatment;

(H) The word Poison for any haz-ardous substance which is defined as ‘‘highly toxic’’ by section 2(h) of the act (restated in paragraph (b)(6) of this section);

(I) Instructions for handling and stor-age of packages which require special care in handling or storage; and

(J) The statement (1) ‘‘Keep out of the reach of children’’ or its practical equivalent, or, (2) if the article is in-tended for use by children and is not a banned hazardous substance, adequate directions for the protection of chil-dren from the hazard; and

(ii) On which any statements re-quired under section 2(p)(1) of the act (restated in paragraph (b)(14)(i) of this section) are located prominently and are in the English language in con-spicuous and legible type in contrast by typography, layout, or color with other printed matter on the label.

Misbranded hazardous substance also means a household substance as de-fined in section 2(2)(D) of the Poison Prevention Packaging Act of 1970 if it is a substance described in section 2(f)(1) of the Federal Hazardous Sub-stances Act (restated in paragraph (b)(4)(i)(A) of this section) and its pack-aging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Preven-tion Packaging Act of 1970.

(15)(i) Banned hazardous substance means:

(A) Any toy, or other article intended for use by children, which is a haz-ardous substance, or which bears or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is entrusted; or

(B) Any hazardous substance in-tended, or packaged in a form suitable, for use in the household, which the Commission by regulation classifies as a ‘‘banned hazardous substance’’ on the basis of a finding that, notwith-standing such cautionary labeling as is or may be required under the act for that substance, the degree or nature of the hazard involved in the presence or


423


use of such substance in households is such that the objective of the protec-tion of the public health and safety can be adequately served only by keeping such substance, when so intended or packaged, out of the channels of inter-state commerce; Provided, That the Commission by regulation (1) shall ex-empt from section 2(q)(1)(A) of the act (restated in paragraph (b)(15)(i)(A) of this section) articles, such as chem-istry sets, which by reason of their functional purpose require the inclu-sion of the hazardous substance in-volved, or necessarily present an elec-trical, mechanical, or thermal hazard, and which bear labeling giving ade-quate directions and warnings for safe use and are intended for use by chil-dren who have attained sufficient ma-turity, and may reasonably be ex-pected, to read and heed such direc-tions and warnings, and (2) shall ex-empt from section 2(q)(1)(A) of the act (restated in paragraph (b)(15)(i)(A) of this section), and provide for the label-ing of, common fireworks (including toy paper caps, cone fountains, cyl-inder fountains, whistles without re-port, and sparklers) to the extent that the Commission determines that such articles can be adequately labeled to protect the purchasers and users there-of.

(ii) Proceedings for the issuance, amendment, or repeal of regulations pursuant to section 2(q)(1)(B) of the act (restated in paragraph (b)(15)(i)(B) of this section) shall be governed by the provisions of section 701 (e), (f), and (g) of the Federal Food, Drug, and Cos-metic Act: Provided, That if the Com-mission finds that the distribution for household use of the hazardous sub-stance involved presents an imminent hazard to the public health, the Com-mission may by order published in the FEDERAL REGISTER give notice of such finding, and thereupon such substance when intended or offered for household use, or when so packaged as to be suit-able for such use, shall be deemed to be a ‘‘banned hazardous substance’’ pend-ing the completion of proceedings re-lating to the issuance of such regula-tions.

(16) ‘‘Electrical hazard’’—an article may be determined to present an elec-trical hazard if, in normal use or when

subjected to reasonably foreseeable damage or abuse, its design or manu-facture may cause personal injury or illness by electric shock.

(17) ‘‘Mechanical hazard’’—an article may be determined to present a me-chanical hazard if, in normal use or when subjected to reasonably foresee-able damage or abuse, its design or manufacture presents an unreasonable risk of personal injury or illness:

(i) From fracture, fragmentation, or disassembly of the article;

(ii) From propulsion of the article (or any part or accessory thereof);

(iii) From points or other protru-sions, surfaces, edges, openings, or clo-sures;

(iv) From moving parts; (v) From lack or insufficiency of con-

trols to reduce or stop motion; (vi) As a result of self-adhering char-

acteristics of the article; (vii) Because the article (or any part

or accessory thereof) may be aspirated or ingested;

(viii) Because of instability; or (ix) Because of any other aspect of

the article’s design or manufacture. (18) ‘‘Thermal hazard’’—an article

may be determined to present a ther-mal hazard if, in normal use or when subjected to reasonably foreseeable damage or abuse, its design or manu-facture presents an unreasonable risk of personal injury or illness because of heat as from heated parts, substances, or surfaces.

(c) Certain statutory definitions inter-preted, supplemented, or provided with al-ternatives. The following items inter-pret, supplement, or provide alter-natives to definitions set forth in sec-tion 2 of the act (and restated in para-graph (b) of this section):

(1) To provide flexibility as to the number of animals tested, the fol-lowing is an alternative to the defini-tion of ‘‘highly toxic’’ in section 2(h) of the act (and paragraph (b)(6) of this section); Highly toxic means:

(i) A substance determined by the Commission to be highly toxic on the basis of human experience; and/or

(ii) A substance that produces death within 14 days in half or more than half of a group of:

(A) White rats (each weighing be-tween 200 and 300 grams) when a single


424

16 CFR Ch. II (1–1–10 Edition) § 1500.3

dose of 50 milligrams or less per kilo-gram of body weight is administered orally;

(B) White rats (each weighing be-tween 200 and 300 grams) when a con-centration of 200 parts per million by volume or less of gas or vapor, or 2 mil-ligrams per liter by volume or less of mist or dust, is inhaled continuously for 1 hour or less, if such concentration is likely to be encountered by man when the substance is used in any rea-sonably foreseeable manner; and/or

(C) Rabbits (each weighing between 2.3 and 3.0 kilograms) when a dosage of 200 milligrams or less per kilogram of body weight is administered by contin-uous contact with the bare skin for 24 hours or less by the method described in § 1500.40. The number of animals tested shall be sufficient to give a statistically signifi-cant result and shall be in conformity with good pharmacological practices.

(2) To give specificity to the defini-tion of ‘‘toxic’’ in section 2(g) of the act (and restated in paragraph (b)(5) of this section), the following supple-ments that definition. The following categories are not intended to be inclu-sive.

(i) Acute toxicity. Toxic means any substance that produces death within 14 days in half or more than half of a group of:

(A) White rats (each weighing be-tween 200 and 300 grams) when a single dose of from 50 milligrams to 5 grams per kilogram of body weight is admin-istered orally. Substances falling in the toxicity range between 500 milligrams and 5 grams per kilogram of body weight will be considered for exemp-tion from some or all of the labeling requirements of the act, under § 1500.82, upon a showing that such labeling is not needed because of the physical form of the substances (solid, a thick plastic, emulsion, etc.), the size or clo-sure of the container, human experi-ence with the article, or any other rel-evant factors;

(B) White rats (each weighing be-tween 200 and 300 grams) when an at-mospheric concentration of more than 200 parts per million but not more than 20,000 parts per million by volume of gas or vapor, or more than 2 but not more than 200 milligrams per liter by

volume of mist or dust, is inhaled con-tinuously for 1 hour or less, if such concentration is likely to be encoun-tered by man when the substance is used in any reasonably foreseeable manner: and/or

(C) Rabbits (each weighing between 2.3 and 3.0 kilograms) when a dosage of more than 200 milligrams but not more than 2 grams per kilogram of body weight is administered by continuous contact with the bare skin for 24 hours by the method described in § 1500.40.

The number of animals tested shall be sufficient to give a statistically signifi-cant result and shall be in conformity with good pharmacological practices. ‘‘Toxic’’ also applies to any substance that is ‘‘toxic’’ (but not ‘‘highly toxic’’) on the basis of human experience.

(ii) Chronic toxicity. A substance is toxic because it presents a chronic haz-ard if it falls into one of the following categories. (For additional information see the chronic toxicity guidelines at 16 CFR 1500.135.)

(A) For Carcinogens. A substance is toxic if it is or contains a known or probable human carcinogen.

(B) For Neurotoxicological Toxicants. A substance is toxic if it is or contains a known or probable human neurotoxin.

(C) For Developmental or Reproductive Toxicants. A substance is toxic if it is or contains a known or probable human developmental or reproductive toxicant.

(3) The definition of corrosive in sec-tion 2(i) of the act (restated in para-graph (b)(7) of this section) is inter-preted to also mean the following: Cor-rosive means a substance that causes visible destruction or irreversible al-terations in the tissue at the site of contact. A test for a corrosive sub-stance is whether, by human experi-ence, such tissue destruction occurs at the site of application. A substance would be considered corrosive to the skin if, when tested on the intact skin of the albino rabbit by the technique described in § 1500.41, the structure of the tissue at the site of contact is de-stroyed or changed irreversibly in 24 hours or less. Other appropriate tests should be applied when contact of the substance with other than skin tissue is being considered.


425


(4) The definition of irritant in section 2(j) of the act (restated in paragraph (b)(8) of this section) is supplemented by the following: Irritant includes ‘‘pri-mary irritant to the skin’’ as well as substances irritant to the eye or to mucous membranes. Primary irritant means a substance that is not corrosive and that human experience data indi-cate is a primary irritant and/or means a substance that results in an empir-ical score of five or more when tested by the method described in § 1500.41. Eye irritant means a substance that human experience data indicate is an irritant to the eye and/or means a sub-stance for which a positive test is ob-tained when tested by the method de-scribed in § 1500.42.

(5) The definition of strong sensitizer in section 2(k) of the Federal Haz-ardous Substances Act (restated in 16 CFR 1500.3(b)(9)) is supplemented by the following definitions:

(i) Sensitizer. A sensitizer is a sub-stance that will induce an immunologically-mediated (allergic) response, including allergic photosensitivity. This allergic reaction will become evident upon reexposure to the same substance. Occasionally, a sensitizer will induce and elicit an al-lergic response on first exposure by vir-tue of active sensitization.

(ii) Strong. In determining that a sub-stance is a ‘‘strong’’ sensitizer, the Commission shall consider the avail-able data for a number of factors. These factors should include any or all of the following (if available): Quan-titative or qualitative risk assessment, frequency of occurrence and range of severity of reactions in healthy or sus-ceptible populations, the result of ex-perimental assays in animals or hu-mans (considering dose-response fac-tors), with human data taking prece-dence over animal data, other data on potency or bioavailability of sensi-tizers, data on reactions to a cross-re-acting substance or to a chemical that metabolizes or degrades to form the same or a cross-reacting substance, the threshold of human sensitivity, epide-miological studies, case histories, oc-cupational studies, and other appro-priate in vivo and in vitro test studies.

(iii) Severity of reaction. The minimal severity of reaction for the purpose of

designating a material as a ‘‘strong sensitizer’’ is a clinically important al-lergic reaction. For example, strong sensitizers may produce substantial ill-ness, including any or all of the fol-lowing: physical discomfort, distress, hardship, and functional or structural impairment. These may, but not nec-essarily, require medical treatment or produce loss of functional activities.

(iv) Significant potential for causing hypersensitivity. ‘‘Significant potential for causing hypersensitivity’’ is a rel-ative determination that must be made separately for each substance. It may be based upon the chemical or func-tional properties of the substance, doc-umented medical evidence of allergic reactions obtained from epidemiolog-ical surveys or individual case reports, controlled in vitro or in vivo experi-mental assays, or susceptibility pro-files in normal or allergic subjects.

(v) Normal living tissue. The allergic hypersensitivity reaction occurs in normal living tissues, including the skin and other organ systems, such as the respiratory or gastrointestinal tract, either singularly or in combina-tion, following sensitization by con-tact, ingestion, or inhalation.

(6) The Consumer Product Safety Commission, by the regulations pub-lished in this section, defines the terms extremely flammable, flammable, and com-bustible, appearing in section 2(1) of the Federal Hazardous Substances Act, as follows:

(i) The term extremely flammable shall apply to any substance which has a flashpoint at or below 20 °F (¥6.7 °C) as determined by the test method de-scribed at § 1500.43a, except that, any mixture having one component or more with a flashpoint higher than 20 °F (¥6.7 °C) which comprises at least 99 percent of the total volume of the mix-ture is not considered to be an ex-tremely flammable substance.

(ii) The term flammable shall apply to any substance having a flashpoint above 20 °F (¥6.7 °C) and below 100 °F (37.8 °C), as determined by the method described at § 1500.43a, except that:

(A) Any mixture having one compo-nent or more with a flashpoint at or above 100 °F (37.8 °C) which comprises at least 99 percent of the total volume


426

16 CFR Ch. II (1–1–10 Edition) § 1500.3

of the mixture is not considered to be a flammable substance; and

(B) Any mixture containing 24 per-cent or less of water miscible alcohols, by volume, in aqueous solution is not considered to be flammable if the mix-ture does not present a significant flammability hazard when used by con-sumers.

(iii) The term combustible shall apply to any substance having a flashpoint at or above 100 °F (37.8 °C) to and includ-ing 150 °F (65.6 °C) as determined by the test method described at § 1500.43a, ex-cept that:

(A) Any mixture having one compo-nent or more with a flashpoint higher than 150 °F (65.6 °C) which comprises at least 99 percent of the total volume of the mixture is not considered to be a combustible hazardous substance; and

(B) Any mixture containing 24 per-cent or less of water miscible alcohols, by volume, in aqueous solution is not considered to be combustible if the mixture does not present a significant flammability hazard when used by con-sumers.

(iv) To determine flashpoint tem-peratures for purposes of enforcing and administering requirements of the Fed-eral Hazardous Substances Act applica-ble to ‘‘extremely flammable,’’ ‘‘flam-mable,’’ and ‘‘combustible’’ hazardous substances, the Commission will follow the procedures set forth in § 1500.43a. However, the Commission will allow manufacturers and labelers of sub-stances and products subject to those requirements to rely on properly con-ducted tests using the Tagliabue open- cup method which was in effect prior to the issuance of § 1500.43a (as published at 38 FR 27012, September 27, 1973, and set forth below), and the defintions of the terms ‘‘extremely flammable,’’ ‘‘flammable,’’ and ‘‘combustible’’ in this section before its amendment (as published at 38 FR 27012, September 27, 1983, and amended 38 FR 30105, Novem-ber 1, 1973, set forth in the note fol-lowing this section) if all of the fol-lowing conditions are met:

(A) The substance or product was subject to and complied with the re-quirements of the Federal Hazardous Substances Act for ‘‘extremely flam-mable,’’ ‘‘flammable,’’ or ‘‘combus-

tible’’ hazardous substances before the effective date of § 1500.43a; and

(B) No change has been made to the formulation or labeling of such sub-stance or product after the effective date of § 1500.43a, prescribing a closed- cup test apparatus and procedure.

(v) Extremely flammable solid means a solid substance that ignites and burns at an ambient temperature of 80 °F or less when subjected to friction, percus-sion, or electrical spark.

(vi) Flammable solid means a solid substance that, when tested by the method described in § 1500.44, ignites and burns with a self-sustained flame at a rate greater than one-tenth of an inch per second along its major axis.

(vii) Extremely flammable contents of self-pressurized container means con-tents of a self-pressurized container that, when tested by the method de-scribed in § 1500.45, a flashback (a flame extending back to the dispenser) is ob-tained at any degree of valve opening and the flashpoint, when tested by the method described in § 1500.43a is less than 20 °F (¥6.7 °C).

(viii) Flammable contents of self-pres-surized container means contents of a self-pressurized container that, when tested by the method described in § 1500.45, a flame projection exceeding 18 inches is obtained at full valve open-ing, or flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening.

(7) The definition of hazardous sub-stance in section 2(f)(1)(A) of the act (restated in paragraph (b)(4)(i)(A) of this section) is supplemented by the following definitions or interpretations or terms used therein:

(i) A substance or mixture of sub-stances that ‘‘generates pressure through decomposition, heat, or other means’’ is a hazardous substance:

(A) If it explodes when subjected to an electrical spark, percussion, or the flame of a burning paraffin candle for 5 seconds or less.

(B) If it expels the closure of its con-tainer, or bursts its container, when held at or below 130 °F. for 2 days or less.

(C) If it erupts from its opened con-tainer at a temperature of 130 °F. or less after having been held in the closed container at 130 °F. for 2 days.


427


(D) If it comprises the contents of a self-pressurized container.

(ii) Substantial personal injury or ill-ness means any injury or illness of a significant nature. It need not be se-vere or serious. What is excluded by the word ‘‘substantial’’ is a wholly in-significant or negligible injury or ill-ness.

(iii) Proximate result means a result that follows in the course of events without an unforeseeable, intervening, independent cause.

(iv) Reasonably foreseeable handling or use includes the reasonably foreseeable accidental handling or use, not only by the purchaser or intended user of the product, but by all others in a house-hold, especially children.

(8) The definition of ‘‘radioactive substance’’ in section 2(m) of the act (restated in paragraph (b)(11) of this section) is supplemented by the fol-lowing: Radioactive substance means a substance which, because of nuclear in-stability, emits electromagnetic and/or particulate radiation capable of pro-ducing ions in its passage through mat-ter. Source materials, special nuclear material, and byproduct materials de-scribed in section 2(f)(3) of the act are exempt.

(9) In the definition of ‘‘label’’ in sec-tion 2(n) of the act (restated in para-graph (b)(12) of this section), a provi-sion stipulates that words, statements, or other information required to be on the label must also appear on all ac-companying literature where there are directions for use, written or other-wise. To make this provision more spe-cific, ‘‘accompanying literature’’ is in-terpreted to mean any placard, pam-phlet, booklet, book, sign, or other written, printed, or graphic matter or visual device that provides directions for use, written or otherwise, and that is used in connection with the display, sale, demonstration, or merchandising of a hazardous substance intended for or packaged in a form suitable for use in the household or by children.

(10) The definition of ‘‘misbranded hazardous substance’’ in section 2(p) of this act (restated in paragraph (b)(14) of this section) is supplemented by the following definitions or interpretations of terms used therein:

(i) Hazardous substances intended, or packaged in a form suitable, for use in the household means any hazardous sub-stance, whether or not packaged, that under any customary or reasonably foreseeable condition of purchase, stor-age, or use may be brought into or around a house, apartment, or other place where people dwell, or in or around any related building or shed in-cluding, but not limited to, a garage, carport, barn, or storage shed. The term includes articles, such as polishes or cleaners, designed primarily for pro-fessional use but which are available in retail stores, such as hobby shops, for nonprofessional use. Also included are items, such as antifreeze and radiator cleaners, that although principally for car use may be stored in or around dwelling places. The term does not in-clude industrial supplies that might be taken into a home by a serviceman. An article labeled as, and marketed solely for, industrial use does not become sub-ject to this act because of the possi-bility that an industrial worker may take a supply for his own use. Size of unit or container is not the only index of whether the article is suitable for use in or around the household; the test shall be whether under any reason-ably foreseeable condition of purchase, storage, or use the article may be found in or around a dwelling.

(ii) Conspicuously in section 2(p)(1) of the act and prominently and conspicuous in section 2(p)(2) of the act mean that, under customary conditions of pur-chase, storage, and use, the required information shall be visible, notice-able, and in clear and legible English. Some factors affecting a warning’s prominence and conspicuousness are: Location, size of type, and contrast of printing against background. Also bearing on the effectiveness of a warn-ing might be the effect of the package contents if spilled on the label.

NOTE: The definitions of extremely flam-mable, flammable, and combustible hazardous substances set forth above in paragraphs (b)(10) and (c)(6) are effective August 10, 1987. The definitions remaining in effect until Au-gust 10, 1987, as published at 38 FR 27012, Sept. 27, 1973, and amended at 38 FR 30105, Nov. 1, 1973, are set forth below. Manufactur-ers and labelers of products subject to the Federal Hazardous Substances Act may con-tinue to use these definitions for labeling of


428

16 CFR Ch. II (1–1–10 Edition) § 1500.4

those products under the conditions set forth in § 1500.3(c)(6)(iv), as amended.

(b)(10) Extremely flammable shall apply to any substance which has a flashpoint at or below 20 °F. as determined by the Tagliabue Open Cup Tester; flammable shall apply to any substance which has a flashpoint of above 20 °F., to and including 80 °F., as deter-mined by the Tagliabue Open Cup Tester; and combustible shall apply to any substance which has a flashpoint above 80 °F. to and in-cluding 150 °F., as determined by the Tagliabue Open Cup Tester; except that the flammability or combustibility of solids and of the contents of self-pressurized containers shall be determined by methods found by the Commission to be generally applicable to such materials or containers, respectively, and established by regulations issued by the Commission, which regulations shall also de-fine the terms flammable, combustible, and ex-tremely flammable in accord with such meth-ods.

* * * * *

(c)(6)(i) Extremely flammable means any sub-stance that has a flashpoint at or below 20 °F. as determined by the method described in § 1500.43.

(ii) Flammable means any substance that has a flashpoint of above 20 °F., to and in-cluding 80 °F., as determined by the method described in § 1500.43.

[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 30105, Nov. 1, 1973; 49 FR 22465, May 30, 1984; 51 FR 28536, Aug. 8, 1986; 51 FR 29096, Aug. 14, 1986; 51 FR 30209, Aug. 25, 1986; 57 FR 46669, Oct. 9, 1992]

§ 1500.4 Human experience with haz-ardous substances.

(a) Reliable data on human experi-ence with any substance should be taken into account in determining whether an article is a ‘‘hazardous sub-stance’’ within the meaning of the act. When such data give reliable results different from results with animal data, the human experience takes prec-edence.

(b) Experience may show that an ar-ticle is more or less toxic, irritant, or corrosive to man than to test animals. It may show other factors that are im-portant in determining the degree of hazard to humans represented by the substance. For example, experience shows that radiator antifreeze is likely to be stored in the household or garage and likely to be ingested in significant quantities by some persons. It also shows that a particular substance in

liquid form is more likely to be in-gested than the same substance in a paste or a solid and that an aerosol is more likely to get into the eyes and the nasal passages than a liquid.

§ 1500.5 Hazardous mixtures. For a mixture of substances, the de-

termination of whether the mixture is a ‘‘hazardous substance’’ as defined by section 2(f) of the act (repeated in § 1500.3(b)(4)) should be based on the physical, chemical, and pharma-cological characteristics of the mix-ture. A mixture of substances may therefore be less hazardous or more hazardous than its components because of synergistic or antagonistic reac-tions. It may not be possible to reach a fully satisfactory decision concerning the toxic, irritant, corrosive, flam-mable, sensitizing, or pressure-gener-ating properties of a substance from what is known about its components or ingredients. The mixture itself should be tested.

§ 1500.12 Products declared to be haz-ardous substances under section 3(a) of the act.

(a) The Commission finds that the following articles are hazardous sub-stances within the meaning of the act because they are capable of causing substantial personal injury or substan-tial illness during or as a proximate re-sult of any customary or reasonably foreseeable handling or use:

(1) Charcoal briquettes and other forms of charcoal in containers for re-tail sale and intended for cooking or heating.

(2) Metal-cored candlewicks that have a lead content of more than 0.06 percent of the total weight of the metal core, and candles made with such wicks.

(b) [Reserved]

[38 FR 27012, Sept. 27, 1973, as amended at 68 FR 19147, Apr. 18, 2003]

§ 1500.13 Listing of ‘‘strong sensitizer’’ substances.

On the basis of frequency of occur-rence and severity of reaction informa-tion, the Commission finds that the following substances have a significant potential for causing hypersensitivity and therefore meet the definition for


429


‘‘strong sensitizer’’ in section 2(k) of the act (repeated in § 1500.3(b)(9)):

(a) Paraphenylenediamine and prod-ucts containing it.

(b) Powdered orris root and products containing it.

(c) Epoxy resins systems containing in any concentration ethylenediamine, diethylenetriamine, and diglycidyl ethers of molecular weight of less than 200.

(d) Formaldehyde and products con-taining 1 percent or more of formalde-hyde.

(e) Oil of bergamot and products con-taining 2 percent or more of oil of ber-gamot.

§ 1500.14 Products requiring special labeling under section 3(b) of the act.

(a) Human experience, as reported in the scientific literature and to the Poi-son Control Centers and the National Clearing House for Poison Control Cen-ters, and opinions of informed medical experts establish that the following substances are hazardous:

(1) Diethylene glycol and mixtures containing 10 percent or more by weight of diethylene glycol.

(2) Ethylene glycol and mixtures con-taining 10 percent or more by weight of ethylene glycol.

(3) Products containing 5 percent or more by weight of benzene (also known as benzol) and products containing 10 percent or more by weight of toluene (also known as toluol), xylene (also known as xylol), or petroleum dis-tillates such as kerosine, mineral seal oil, naphtha, gasoline, mineral spirits, stoddard solvent, and related petro-leum distillates.

(4) Methyl alcohol (methanol) and mixtures containing 4 percent or more by weight of methyl alcohol (meth-anol).

(5) Turpentine (including gum tur-pentine, gum spirits of turpentine, steam-distilled wood turpentine, sul-fate wood turpentine, and destructively distilled wood turpentine) and mix-tures containing 10 percent or more by weight of such turpentine.

(b) The Commission finds that the following substances present special hazards and that, for these substances, the labeling required by section 2(p)(1)

of the act is not adequate for the pro-tection of the public health. Under sec-tion 3(b) of the act, the following spe-cific label statements are deemed nec-essary to supplement the labeling re-quired by section 2(p)(1) of the act:

(1) Diethylene glycol. Because diethylene glycol and mixtures con-taining 10 percent or more by weight of diethylene glycol are commonly mar-keted, stored, and used in a manner in-creasing the possibility of accidental ingestion, such products shall be la-beled with the signal word ‘‘warning’’ and the statement ‘‘Harmful if swal-lowed.’’

(2) Ethylene glycol. Because ethylene glycol and mixtures containing 10 per-cent or more by weight of ethylene gly-col are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, such products shall be labeled with the signal word ‘‘warning’’ and the state-ment ‘‘Harmful or fatal if swallowed.’’

(3) Benzene, toluene, xylene, petroleum distillates. (i) Because inhalation of the vapors of products containing 5 percent or more by weight of benzene may cause blood dyscrasias, such products shall be labeled with the signal word ‘‘danger,’’ the statement of hazard ‘‘Vapor harmful,’’ the word ‘‘poison,’’ and the skull and crossbones symbol. If the product contains 10 percent or more by weight of benzene, it shall bear the additional statement of haz-ard ‘‘Harmful or fatal if swallowed’’ and the additional statement ‘‘Call physician immediately.’’

(ii) Because products containing 10 percent or more by weight of toluene, xylene, or any of the other substances listed in paragraph (a)(3) of this section may be aspirated into the lungs, with resulting chemical pneumonitis, pneu-monia, and pulmonary edema, such products shall be labeled with the sig-nal word ‘‘danger,’’ the statement or hazard ‘‘Harmful or fatal if swal-lowed,’’ and the statement ‘‘Call physi-cian immediately.’’

(iii) Because inhalation of the vapor of products containing 10 percent or more by weight of toluene or xylene may cause systemic injury, such prod-ucts shall bear the statement of hazard ‘‘Vapor harmful’’ in addition to the


430

16 CFR Ch. II (1–1–10 Edition) § 1500.14

statements prescribed in paragraph (b)(3)(ii) of this section.

(4) Methyl alcohol (methanol). Because death and blindness can result from the ingestion of methyl alcohol, the label for this substance and for mixtures containing 4 percent or more by weight of this substance shall include the sig-nal word ‘‘danger,’’ the additional word ‘‘poison,’’ and the skull and crossbones symbol. The statement of hazard shall include ‘‘Vapor harmful’’ and ‘‘May be fatal or cause blindness if swallowed.’’ The label shall also bear the statement ‘‘Cannot be made nonpoisonous.’’

(5) Turpentine. Because turpentine (including gum turpentine, gum spirits of turpentine, steam-distilled wood tur-pentine, sulfate wood turpentine, and destructively distilled wood turpen-tine) and products containing 10 per-cent or more by weight of such turpen-tine, in addition to oral toxicity result-ing in systemic poisoning, may be aspi-rated into the lungs with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word ‘‘dan-ger’’ and the statement of hazard ‘‘Harmful or fatal if swallowed.’’

(6) Charcoal. Charcoal briquettes and other forms of charcoal in containers for retail sale and intended for cooking or heating.

(i)(A) Because inhalation of the car-bon monoxide produced by burning

charcoal indoors or in confined areas may cause serious injury or death, con-tainers of such products packaged be-fore November 3, 1997, shall bear the following borderlined statement:

WARNING: Do Not Use for Indoor Heating or Cooking Unless Ventilation Is Provided for Exhausting Fumes to Outside. Toxic Fumes May Accumulate and Cause Death

(B) For bags of charcoal packaged be-fore November 3, 1997, the statement specified in paragraph (b)(6)(i) of this section shall appear within a heavy borderline in a color sharply con-trasting to that of the background, on both front and back panels in the upper 25 percent of the panels of the bag at least 2 inches below the seam, and at least 1 inch above any reading material or design elements in type size as fol-lows: The signal word ‘‘WARNING’’ shall appear in capital letters at least three-eighths inch in height; the re-maining text of the warning statement shall be printed in letters at least three-sixteenths inch in height.

(ii)(A) Because inhalation of the car-bon monoxide produced by burning charcoal indoors or in confined areas can cause serious injury or death, con-tainers of such products packaged on or after November 3, 1997, shall bear the following borderlined label.

(B) Except as provided in paragraph (b)(6)(ii)(C) of this section, the fol-lowing requirements apply to bags of charcoal subject to paragraph (b)(6)(ii)(A) of this section. The label

specified in paragraph (b)(6)(ii)(A) of this section shall appear within a heavy borderline, in a color sharply contrasting to that of the background, on both the front and back panels in

VerDate Nov<24>2008 15:16 Feb 23, 2010 Jkt 220052 PO 00000 Frm 00440 Fmt 8010 Sfmt 8010 Q:\16\16V2 ofr150 PsN: PC150 ER

03M

Y96

.051

</G

PH

>

431


the upper 25 percent of the panels of the bag, and with the outer edge of the borderline at least 2.54 cm (1 inch) below the seam and at least 2.54 cm (1 inch) above any other reading material or design elements. The signal word ‘‘WARNING’’ shall be in bold capital letters in at least 7.14 mm (9⁄32 inch) type. The remaining text of the warn-ing statement shall be in at least 4.763 mm (3⁄16 inch) type. The phrase ‘‘CAR-BON MONOXIDE HAZARD’’ shall be in bold. This phrase and the word ‘‘NEVER’’ shall be in all capital let-ters. The lettering shall have a strokewidth-to-height ratio of 1:6 to 1:8. The label shall be at least 50.8 mm (2 inches) high and 147.5 mm (513⁄16 inches) wide. The label’s lettering, spacing between the bottom of the let-ters of one line and the top of the let-ter of the next line, and pictogram shall have the size relation to each other and to the remainder of the label shown in paragraph (b)(6)(ii)(A) of this section.

(C) For bags of charcoal subject to paragraph (b)(6)(ii)(A) of this section that are 6 inches or less wide, the min-imum label height may be reduced to 38 mm (1.5 inches) and the minimum width may be reduced to 139.7 mm (5.5 inches). The signal word ‘‘WARNING’’ shall be in capital letters in at least 6.32 mm (0.249 inch) type. The remain-ing text of the warning shall be in at least 4.23 mm (0.166 inch) type. All other requirements of paragraphs 6(b)(ii) (A) and (B) of this section shall apply to these bags.

(7) Fireworks devices. Because of the special hazards presented by fireworks devices if not used in a certain manner, the following listed fireworks devices shall be labeled as indicated:

(i) Fountains.

WARNING (OR CAUTION)

FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive).

Use only under [close] adult supervision. (Use of the word close is optional.)

For outdoor use only. Place on level surface. Light fuse and get away.

(ii) California candles.

WARNING (OR CAUTION) EMITS SHOWERS OF SPARKS


For outdoor use only. Hold in hand at bottom of tube. Point away from body so that neither end

points toward body. (iii) Spike and handle cylindrical foun-

tains. (A) Spike fountains.



For outdoor use only. Stick firmly in ground in an upright posi-

tion. Do not hold in hand. Light fuse and get away.

(B) Handle fountains.



For outdoor use only. Hold in hand—point away from body. Light fuse.

(iv) Roman Candles.

WARNING (OR CAUTION) SHOOTS FLAMING BALLS


For outdoor use only. Stick butt end in ground. Do not hold in hand. Light fuse and get away.

(v) Rockets with sticks.

WARNING (OR CAUTION) FLAMMABLE


For outdoor use only. Place in wooden trough or iron pipe at 75°

angle, pointing away from people or flam-mable material.

Do not hold in hand. Light fuse and get away.

(vi) Wheels.

WARNING (OR CAUTION) FLAMMABLE (OR EMITS SHOWERS OF SPARKS, IF MORE DESCRIPTIVE)


For outdoor use only. Attach securely by means of a nail through

the hole (or place on hard flat surface, for ground spinners).

Light fuse and get away. (vii) Illuminating torches.


432

16 CFR Ch. II (1–1–10 Edition) § 1500.14



For outdoor use only. Hold in hand—point away from body, cloth-

ing, or other flammable material (or place upright on level ground. Do not hold in hand, if more descriptive).

Light fuse (or light fuse and get away, if more descriptive). (viii) Sparklers. On the front and back panels:


On the side, front, back, top, or bottom panel.

CAUTION


For outdoor use only. Do not touch glowing wire (or do not touch

hot plastic, wood, etc., if more descriptive). Hold in hand with arm extended away from

body. Keep burning end or sparks away from wear-

ing apparel or other flammable material. (ix) Mines and shells.

WARNING (OR CAUTION) EMITS SHOWERS OF SPARKS (OR SHOOTS FLAMING BALLS, IF MORE DESCRIPTIVE)


For outdoor use only. Place on hard smooth surface (or place up-

right on level ground, if more descriptive). Do not hold in hand. Light fuse and get away.

(x) Whistles without report.


SHOOTS WHISTLE IN AIR (if applicable) Use only under [close] adult supervision.

(Use of the word close is optional.) For outdoor use only. Do not hold in hand. Light fuse and get away.

(xi) Toy smoke devices and flitter de-vices.



For outdoor use only. Do not hold in hand. Light fuse and get away.

(xii) Helicopter-type rockets.



For outdoor use only. Place on hard, open surface. Light fuse and get away.

(xiii) Party poppers.



Do not point either end toward face or other person.

Hold in hand—jerk string. (xiv) Missile-type rockets.



For outdoor use only. Place on hard, open surface. Light fuse and get away.

(xv) Labeling—General. Any fireworks device not required to have a specific label as indicated above shall carry a warning label indicating to the user where and how the item is to be used and necessary safety precautions to be observed. All labels required under this section shall comply with the require-ments of § 1500.121 of these regulations. (See also § 1500.17(a) (3), (8) and (9); § 1500.83(a)(27); § 1500.85(a)(2); and part 1507).

(8) Art materials.

NOTE: The Labeling of Hazardous Art Ma-terials Act (‘‘LHAMA’’), 15 U.S.C. 1277 (Pub. L. 100–695, enacted November 18, 1988) pro-vides that, as of November 18, 1990, ‘‘the re-quirements for the labeling of art materials set forth in the version of the standard of the American Society for Testing and Materials [‘‘ASTM’’] designated D–4236 that is in effect on [November 18, 1988] * * * shall be deemed to be a regulation issued by the Commission under section 3(b)’’ of the Federal Hazardous Substances Act, 15 U.S.C. 1262(b). For the convenience of interested persons, the Com-mission is including the requirements of ASTM D–4236 in paragraph (b)(8)(i) of this section, along with other requirements (stat-ed in paragraph (b)(8)(ii) of this section) made applicable to art materials by the LHAMA. The substance of the requirements specified in LHAMA became effective on No-vember 18, 1990, as mandated by Congress.


433


(i) ASTM D–4236—(A) Scope—(1) This section describes a procedure for devel-oping precautionary labels for art ma-terials and provides hazard and pre-cautionary statements based upon knowledge that exists in the scientific and medical communities. This section concerns those chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see para-graph (b)(8)(i)(B)(11) of this section) has the potential to produce a chronic ad-verse health effect(s).

(2) This section applies exclusively to art materials packaged in sizes in-tended for individual users of any age or those participating in a small group.

(3) Labeling determinations shall consider reasonably foreseeable use or misuse.

(4) Manufacturers or repackagers may wish to have compliance certified by a certifying organization. Guide-lines for a certifying organization are given in paragraph (b)(8)(i)(H) of this section.

(B) Descriptions of Terms Specific to This Standard. (1) Art material or art material product—any raw or proc-essed material, or manufactured prod-uct, marketed or represented by the producer or repackager as intended for and suitable for users as defined herein.

(2) Users—artists or crafts people of any age who create, or recreate in a limited number, largely by hand, works which may or may not have a practical use, but in which aesthetic consider-ations are paramount.

(3) Chronic adverse health effect(s)— a persistent toxic effect(s) that devel-ops over time from a single, prolonged, or repeated exposure to a substance. This effect may result from exposure(s) to a substance that can, in humans, cause sterility, birth defects, harm to a developing fetus or to a nursing infant, cancer, allergenic sensitization, dam-age to the nervous system, or a per-sistent adverse effect to any other organ system.

(4) chronic health hazard(s) (here-after referred to as ‘‘chronic hazard’’)— a health risk to humans, resultant from exposure to a substance that may cause a chronic adverse health effect.

(5) Analytical laboratory—a labora-tory having personnel and apparatus capable of performing quantitative or qualitative analyses of art materials, which may yield information that is used by a toxicologist for evaluation of potentially hazardous materials.

(6) Label—a display of written, print-ed, or graphic matter upon the imme-diate container of any art material product. When the product is unpackaged, or is not packaged in an immediate container intended or suit-able for delivery to users, the label can be a display of such matter directly upon the article involved or upon a tag or other suitable labeling device at-tached to the art material.

(7) Producer—the person or entity who manufactures, processes, or im-ports an art material.

(8) Repackager—the person or entity who obtains materials from producers and without making changes in such materials puts them in containers in-tended for sale as art materials to users.

(9) Sensitizer—a substance known to cause, through an allergic process, a chronic adverse health effect which be-comes evident in a significant number of people on re-exposure to the same substance.

(10) Toxic—applies to any substance that is likely to produce personal in-jury or illness to humans through in-gestion, inhalation, or skin contact.

(11) Toxicologist—an individual who through education, training, and expe-rience has expertise in the field of toxi-cology, as it relates to human expo-sure, and is either a toxicologist or physician certified by a nationally rec-ognized certification board.

(12) Bioavailability—the extent that a substance can be absorbed in a bio-logically active form.

(C) Requirements. (1) The producer or repackager of art materials shall sub-mit art material product formula-tion(s) or reformulation(s) to a toxi-cologist for review, such review to be in accordance with paragraph (b)(8)(l)(D) of this section. The toxi-cologist shall be required to keep prod-uct formulation(s) confidential.

(2) Unless otherwise agreed in writing by the producer or repackager, no one other than the toxicologists shall have


434

16 CFR Ch. II (1–1–10 Edition) § 1500.14

access to the formulation(s); except that the toxicologists shall furnish a patient’s physician, on a confidential basis, the information necessary to di-agnose or treat cases of exposure or ac-cidental ingestion.

(3) The producer or repackager, upon advice given by a toxicologist in ac-cordance with paragraph (b)(8)(i)(D) of this section and based upon generally accepted, well-established evidence that a component substance(s) is known to cause chronic adverse health effects adopt precautionary labeling in accordance with paragraph (b)(8)(i)(E) of this section.

(4) Labeling shall conform to any la-beling practices prescribed by federal and state statutes or regulations and shall not diminish the effect of re-quired acute toxicity warnings.

(5) The producer or repackager shall supply a poison exposure management information source the generic formu-lation information required for dis-semination to poison control centers or shall provide a 24-hour cost-free tele-phone number to poison control cen-ters.

(6) The producer or repackager shall have a toxicologist review as nec-essary, but at least every 5 years, art material product formulation(s) and associated label(s) based upon the then- current, generally accepted, well-estab-lished scientific knowledge.

(7) Statement of Conformance— ‘‘Conforms to ASTM Practice D–4236,’’ or ‘‘Conforms to ASTM D–4236,’’ or ‘‘Conforms to the health requirements of ASTM D–4236.’’ This statement may be combined with other conformance statements. The conformance state-ment should appear whenever practical on the product; however, it shall also be acceptable to place the statement on one or more of the following:

(i) The individual product package, (ii) a display or sign at the point of

purchase, (iii) separate explanatory literature

available on requirements at the point of purchase,

(iv) a response to a formal request for bid or proposal.

(D) Determination of Labeling. (1) An art material is considered to have the potential for producing chronic adverse health effects if any customary or rea-

sonably foreseeable use can result in a chronic hazard.

(2) In making the determination, a toxicologist(s) shall take into account the following:

(i) Current chemical composition of the art material, supplied by an ana-lytical laboratory or by an industrial chemist on behalf of a manufacturer or repackager.

(ii) Current generally accepted, well- established scientific knowledge of the chronic toxic potential of each compo-nent and the total formulation.

(iii) Specific physical and chemical form of the art material product, bio-availability, concentration, and the amount of each potentially chronic toxic component found in the formula-tion.

(iv) Reasonably foreseeable uses of the art material product as determined by consultation with users and other individuals who are experienced in use of the material(s), such as teachers, or by market studies, unless such use in-formation has previously been deter-mined with respect to the specific art material(s) under review.

(v) Potential for known synergism and antagonism of the various compo-nents of the formulation.

(vi) Potentially chronic adverse health effects of decomposition or com-bustion products, if known, from any reasonably foreseeable use of the haz-ardous art material product.

(vii) Opinions of various regulatory agencies and scientific bodies, includ-ing the International Agency for Re-search on Cancer and the National Can-cer Institute, on the potential for chronic adverse health effects of the various components of the formulation.

(3) Based upon the conclusion reached in conformance with review determinations set forth herein, the toxicologist(s) shall recommend pre-cautionary labeling consistent with paragraph (b)(8)(i)(E) of this section.

(E) Labeling Practices—(1) Signal Word. (i) When a signal word for an acute hazard(s) is mandated and a chronic hazard(s) exists, the signal word shall be that for the acute hazard.

(ii) When only a chronic hazard(s) ex-ists, the signal word WARNING shall be used.


435


(iii) The signal word shall be promi-nently visible and set in bold capitals in a size equal to or greater than the statement of potential chronic hazards.

(2) List of Potentially Chronic Haz-ards—Potentially chronic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be stated substantially in accord-ance with the statements listed in paragraph (b)(8)(i)(F) of this section. Potentially chronic hazards noted shall be those that are clinically significant and that might be expected with any reasonably foreseeable use of the art material. The hazards should be grouped in the order of relative de-scending severity.

(3) Name of Chronically Hazardous Component(s)—All components and known decomposition products of the formulation with a potential for chron-ic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be listed promi-nently. Generically equivalent names may be used.

(4) Safe Handling Instructions—Ap-propriate precautionary statements as to work practices, personal protection, and ventilation requirements shall be used substantially conforming with those listed in paragraph (b)(8)(i)(G) of this section.

(5) List of Sensitizing Components— To protect users from known sensi-tizers found within art materials, each label shall contain a list of those sensi-tizers present in sufficient amounts to contribute significantly to a known skin or respiratory sensitization.

(6) Combined Statement—If an art material contains more than one com-ponent capable of causing a chronic ad-verse health effect, or if a single chem-ical can cause several different chronic adverse health effects, the potential ef-fects may be combined into one state-ment.

(7) Information Sources—The pre-cautionary label shall contain a state-ment identifying a source for addi-tional health information substantially in conformance with one of the phrases listed below:

(i) For more health information—(24 hour cost-free U.S. telephone number),

(ii) Contact a physician for more health information, or

(iii) Call your local poison control center for more health information.

(8) Labeling Content, Product Size— Any art material product in a con-tainer larger in size than one fluid ounce (30 ml) (if the product is sold by volume) or one ounce net weight (28 g) (if the product is sold by weight) shall have full precautionary labeling, as de-scribed in paragraph (b)(8)(i) (E) of this section. Any art material product in a container equal to or smaller than one fluid ounce or one ounce net weight shall have a label that includes a signal word in conformance with paragraph (b)(8)(i)(E)(1) of this section and a list of potentially harmful or sensitizing components in conformance with para-graphs (b)(8)(i)(E) (3) and (5) of this sec-tion.

(9) The information described in paragraph (b)(8)(i)(E) of this section must appear on:

(i) The outside container or wrapper, if any, unless it is easily legible through the outside container or wrap-per and

(ii) All accompanying literature where there are directions for use, written or otherwise. Where a product that requires warning labels under paragraphs (b)(8)(i) (D) and (E) of this section is packed within a point-of-sale package that obscures the warning statement(s), the point-of-sale package shall carry the signal word conforming to paragraph (b)(8)(i)(E)(1) and the fol-lowing wording: ‘‘Contains: (list haz-ardous product(s)) that may be harmful if misused. Read cautions on individual containers carefully. Keep out of the reach of children.’’

(10) Statements required under para-graphs (b)(8)(i) (D) and (E) of this sec-tion must be in the English language and located prominently in con-spicuous and legible type in contrast by topography, layout, or color with other printed matter on the label.

(11) Supplemental Information— Where appropriate, more detailed in-formation that relates to chronic haz-ard(s), such as physical properties, de-composition products, detailed safety instructions, or disposal recommenda-tions, shall be included in supple-mental documents, such as Material Safety Data Sheets, technical bro-chures, technical data sheets etc.


436

16 CFR Ch. II (1–1–10 Edition) § 1500.14

(F) chronic Hazard Statements MAY CAUSE STERILITY. CONTACT MAY CAUSE PERMANENT

EYE DAMAGE. MAY BE HARMFUL BY BREATHING

VAPORS/DUSTS. MAY BE HARMFUL IF SWALLOWED. MAY BE HARMFUL BY SKIN CON-

TACT. MAY PRODUCE BIRTH DEFECTS IN

THE DEVELOPING FETUS. MAY BE EXCRETED IN HUMAN

MILK. MAY CAUSE HARM TO THE NURS-

ING INFANT. CANCER AGENT! EXPOSURE MAY

PRODUCE CANCER. CANCER AGENT BASED ON TESTS

WITH LABORATORY ANIMALS. POSSIBLE CANCER AGENT BASED

ON TESTS WITH LABORATORY ANIMALS.

MAY PRODUCE ALLERGIC REAC-TION BY INGESTION/INHALATION/ SKIN CONTACT.

MAY PRODUCE NUMBNESS OR WEAKNESS IN THE EXTREMITIES.

EXPOSURE MAY CAUSE (SPECIFY THE ORGAN(S)) DAMAGE.

HEATING/COMBUSTION MAY CAUSE HAZARDOUS DECOMPOSITION PRODUCTS. (G) Precautionary Statements

Keep out of reach of children. When using do not eat, drink, or

smoke. Wash hands immediately after use. Avoid inhalation/ingestion/skin con-

tact. Avoid fumes from combustion. Keep container tightly closed when not

in use. Store in well-ventilated area. Wear protective clothing (specify

type). Wear protective goggles/face shield. Wear NIOSH-certified mask for dusts/

mists/fumes. Wear NIOSH-certified respirator with

an appropriate cartridge for (specify). Wear NIOSH-certified supplied-air res-

pirator. Use window exhaust fan to remove va-

pors and ensure adequate cross ven-tilation. (Specify explosion-proof if necessary.)

Do not heat above (specify tempera-ture) without adequate ventilation.

Use (specify type) local exhausting hood.

Do not use/mix with (specify material). (ii) The following shall apply with re-

spect to the standard for art materials set forth in § 1500.14(b)(8)(i).

(A) The term art material or art mate-rial product shall mean any substance marketed or represented by the pro-ducer or repackager as suitable for use in any phase of the creation of any work of visual or graphic art of any medium. The term does not include economic poisons subject to the Fed-eral Insecticide, Fungicide, and Rodenticide Act or drugs, devices, or cosmetics subject to the Federal Food, Drug, and Cosmetics Act.

(B) The standard referred to in para-graph (b)(8)(i) of this section applies to art materials intended for users of any age.

(C) Each producer or repackager of art materials shall describe in writing the criteria used to determine whether an art material has the potential for producing chronic adverse health ef-fects. Each producer or repackager shall submit, to the Commission’s Divi-sion of Regulatory Management, Con-sumer Product Safety Commission, Washington, DC 20207, the written de-scription of the criteria described above and a list of art materials that require hazard warning labels under this section. Upon request of the Com-mission, a producer or repackager shall submit to the Commission product for-mulations.

(D) All art materials that require chronic hazard labeling pursuant to this section must include on the label the name and United States address of the producer or repackager of the art materials, an appropriate United States telephone number that can be contacted for more information on the hazards requiring warning labels under this section, and a statement that such art materials are inappropriate for use by children.

(E) If an art material producer or re-packager becomes newly aware of any significant information regarding the hazards of an art material or ways to protect against the hazard, this new in-formation must be incorporated into the labels of such art materials that are manufactured after 12 months from the date of discovery. If a producer or


437


repackager reformulates an art mate-rial, the new formulation must be eval-uated and labeled in accordance with the standard set forth § 1500.14(b)(8)(i).

(F) In determining whether an art material has the potential for pro-ducing chronic adverse health effects, including carcinogenicity and poten-tial carcinogenicity, the toxicologist to whom the substance is referred under the standard described above shall take into account opinions of var-ious regulatory agencies and scientific bodies, including the U.S. Consumer Product Safety Commission (CPSC), the U.S. Environmental Protection Agency (EPA), and the International Agency for Research on Cancer (IARC).

(iii) Pursuant to the LHAMA, the Commission has issued guidelines which, where possible, specify criteria for determining when any customary or reasonably foreseeable use of an art material can result in a chronic haz-ard. These guidelines include criteria for determining when art materials may produce chronic adverse effects in children and adults, criteria for deter-mining which substances contained in art materials have the potential for producing chronic adverse effects and what those effects are, criteria for de-termining the bioavailability of chron-ically hazardous substances contained in art materials when the products are used in a customary or reasonably fore-seeable manner, and criteria for deter-mining acceptable daily intake levels for chronically hazardous substances contained in art materials. Because these guidelines apply to hazardous substances in general as well as to haz-ardous substances in art materials, the guidelines are set forth in § 1500.135 and a definition of ‘‘chronic toxicity’’ is provided in § 1500.3(c)(2)(ii) as part of supplementation of the term ‘‘toxic’’ in section 2(q) of the FHSA.

(iv) Policies and interpretations. (A) For purposes of enforcement pol-

icy, the Commission will not consider as sufficient grounds for bringing an enforcement action under the Labeling of Hazardous Art Materials Act (‘‘LHAMA’’) the failure of the following types of products to meet the require-ments of § 1500.14(b)(8) (i) through (iii).

(1) Products whose intended general use is not to create art (e.g., common

wood pencils, and single colored pens, markers, and chalk), unless the par-ticular product is specifically pack-aged, promoted, or marketed in a man-ner that would lead a reasonable per-son to conclude that it is intended for use as an art material. Factors the Commission would consider in making this determination are how an item is packaged (e.g., packages of multiple colored pencils, chalks, or markers un-less promoted for non-art materials uses are likely to be art materials), how it is marketed and promoted (e.g., pencils and pens intended specifically for sketching and drawing are likely to be art materials), and where it is sold (e.g., products sold in an art supply store are likely to be art materials). The products described in this para-graph do not meet the statutory defini-tion of ‘‘art material.’’

(2) Tools, implements, and furniture used in the creation of a work of art such as brushes, chisels, easels, picture frames, drafting tables and chairs, can-vas stretchers, potter’s wheels, ham-mers, air pumps for air brushes, kilns, and molds.

(3) Surface materials upon which an art material is applied, such as color-ing books and canvas, unless, as a re-sult of processing or handling, the con-sumer is likely to be exposed to a chemical in or on the surface material in a manner which makes that chem-ical susceptible to being ingested, ab-sorbed, or inhaled.

(4) The following materials whether used as a surface or applied to one, un-less, as a result of processing or han-dling, the consumer is likely to be ex-posed to a chemical in or on the sur-face material in a manner which makes that chemical susceptible to being in-gested, absorbed, or inhaled: paper, cloth, plastics, films, yarn, threads, rubber, sand, wood, stone, tile, ma-sonry, and metal.

(B) For purposes of LHAMA enforce-ment policy, the Commission will en-force against materials including, but not limited to, paints, crayons, colored pencils, glues, adhesives, and putties, if such materials are sold as part of an art, craft, model, or hobby kit. The Commission will enforce the LHAMA requirements against paints or other


438

16 CFR Ch. II (1–1–10 Edition) § 1500.15

materials sold separately which are in-tended to decorate art, craft, model, and hobby items. Adhesives, glues, and putties intended for general repair or construction uses are not subject to LHAMA. However, the Commission will enforce the LHAMA requirements against adhesives, glues, and putties sold separately (not part of a kit) if they are intended for art and craft and model construction uses. This para-graph (b)(8)(iv)(B) applies to products introduced into interstate commerce on or after August 14, 1995.

(C) Commission regulations at § 1500.14(b)(8)(i)(C)(7) require that a statement of conformance appear with art materials that have been reviewed in accordance with the Commission standard. The Commission interprets this provision to require a conformance statement regardless of the presence of any chronic hazard warnings.

(D) Nothing in this enforcement statement should be deemed to alter any of the requirements of the Federal Hazardous Substances Act (‘‘FHSA’’), such as, but not limited to, the require-ment that any hazardous substance in-tended or packaged in a form suitable for household use must be labeled in accordance with section 2(p) of the FHSA.

APPENDIX A TO § 1500.14(B)(8)—GUIDELINES FOR A CERTIFYING ORGANIZATION (NOT MAN-DATORY)

(a) The term ‘‘certifying organization,’’ as used in this paragraph, refers to an organiza-tion or an institute that, after assuring that all provisions are met, certifies that an art material does conform to the labeling re-quirements of this practice.

(b) The certifying body may be funded by member manufacturers, but should include users or their representatives, as well as manufacturers’ chemists, on its technical and certifying committees.

(c) Representative samples of art mate-rials, labeled as conforming to this section and bought at retail, should be analyzed at random and from time to time by an analyt-ical laboratory to ensure they are the same as the formulation used by the toxi-cologist(s) for determining labeling require-ments.

(d) The methods used by the toxicologist(s) in review and determination of the need and content of precautionary labeling for poten-tially chronic adverse health effects should be periodically reviewed by an advisory board composed of not less than three or

more than five toxicologists, at least one of whom is certified in toxicology by a nation-ally recognized certification board.

(e) In cases where there is disagreement by participating producers or participating users, with the determination of the toxi-cologist(s), there should be a method where-by the toxicologist’s decision can be pre-sented to the advisory board of toxicologists for arbitration.

[38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22934, June 8, 1976; 48 FR 16, Jan. 3, 1983; 53 FR 3018, Feb. 3, 1988; 57 FR 46669, Oct. 9, 1992; 60 FR 8193, Feb. 27, 1995; 61 FR 19829, May 3, 1996; 61 FR 33175, June 26, 1996]

§ 1500.15 Labeling of fire extin-guishers.

When a substance or mixture of sub-stances labeled for use in or as a fire extinguisher produces substances that are toxic within the meaning of § 1500.3(c) (1) and (2) when used accord-ing to label directions to extinguish a fire, the containers for such substances shall bear the following labeling:

(a) When substances are produced that meet the definition of highly toxic in § 1500.3(c)(1), the signal word ‘‘Dan-ger’’ and the statement of hazard ‘‘Poisonous gases formed when used to extinguish flame or on contact with heat’’ are required labeling.

(b) When substances are produced that meet the definition of toxic in § 1500.3(c)(2), the signal word ‘‘Caution’’ or ‘‘Warning’’ and the statement of hazard ‘‘Dangerous gas formed when used to extinguish flame or on contact with heat’’ are required labeling.

(c) Regardless of whether paragraph (a) or (b) of this section applies, any substance or mixture of substances la-beled for use as a fire extinguisher that, if applied to an electrical fire, would subject the user to the likeli-hood of electrical shock shall be con-spicuously labeled ‘‘Caution: Do not use on electrical wires.’’

(d) The statements specified in para-graphs (a), (b), and (c) of this section shall be in addition to any other that may be required under the act. All such substances or mixtures of substances shall also bear the additional state-ments ‘‘Use in an enclosed place may be fatal’’ and ‘‘Do not enter area until well ventilated and all odor of chem-ical has disappeared.’’


439


§ 1500.17 Banned hazardous sub-stances.

(a) Under the authority of section 2(q)(1)(B) of the act, the Commission declares as banned hazardous sub-stances the following articles because they possess such a degree or nature of hazard that adequate cautionary label-ing cannot be written and the public health and safety can be served only by keeping such articles out of interstate commerce:

(1) Mixtures that are intended pri-marily for application to interior ma-sonry walls, floors, etc., as a water re-pellant treatment and that are ‘‘ex-tremely flammable’’ within the mean-ing of section 2(1) of the act (repeated in § 1500.3(b)(10)).

(2) Carbon tetrachloride and mixtures containing it (including carbon tetra-chloride and mixtures containing it used in fire extinguishers), excluding unavoidable manufacturing residues of carbon tetrachloride in other chemi-cals that under reasonably foreseeable conditions of use do not result in an at-mospheric concentration of carbon tet-rachloride greater than 10 parts per million.

(3) Fireworks devices intended to produce audible effects (including but not limited to cherry bombs, M–80 sa-lutes, silver salutes, and other large firecrackers, aerial bombs, and other fireworks designed to produce audible effects, and including kits and compo-nents intended to produce such fire-works) if the audible effect is produced by a charge of more than 2 grains of pyrotechnic composition; except that this provision shall not apply to such fireworks devices if all of the following conditions are met:

(i) Such fireworks devices are distrib-uted to farmers, ranchers, or growers through a wildlife management pro-gram administered by the U.S. Depart-ment of the Interior (or by equivalent State or local government agencies); and

(ii) Such distribution is in response to a written application describing the wildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and is where other means of control are un-available or inadequate. (See also

§ 1500.14(b)(7); § 1500.17(a) (8) and (9); § 1500.83(a)(27); § 1500.85(a)(2); and part 1507).

(4) Liquid drain cleaners containing 10 percent or more by weight of sodium and/or potassium hydroxide; except that this subparagraph shall not apply to such liquid drain cleaners if pack-aged in accordance with a standard for special packaging of such articles pro-mulgated under the Poison Prevention Packaging Act of 1970 (Pub. L. 91–601, 84 Stat. 1670–74 (15 U.S.C. 1471–76)).

(5) Products containing soluble cya-nide salts, excluding unavoidable man-ufacturing residues of cyanide salts in other chemicals that under reasonable and foreseeable conditions of use will not result in a concentration of cya-nide greater than 25 parts per million.

(6)(i) Any paint or other similar sur-face-coating material intended, or packaged in a form suitable, for use in or around the household that:

(A) Is shipped in interstate commerce after December 31, 1973, and contains lead compounds of which the lead con-tent (calculated as the metal) is in ex-cess of 0.06 percent of the total weight of the contained solids or dried paint film; or

(B) Is shipped in interstate commerce after December 31, 1972, and contains lead compounds of which the lead con-tent (calculated as the metal) is in ex-cess of 0.5 percent of the total weight of the contained solids or dried paint film.

(C) [Reserved] (D) The provisions of paragraph

(a)(6)(i) of this section do not apply to artists’ paints and related materials.

(ii) Any toy or other article intended for use by children that:

(A) Is shipped in interstate commerce after December 31, 1973, and bears any paint or other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) is in excess of 0.06 percent of the total weight of the contained solids or dried paint film; or

(B) Is shipped in interstate commerce after December 31, 1972, and bears any paint or other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) is in excess of 0.5 percent of


440

16 CFR Ch. II (1–1–10 Edition) § 1500.17

the total weight of the contained solids or dried paint film.

(iii) Since the Commission has issued comprehensive regulations for lead- containing paint and certain consumer products bearing such paint at the 0.06 percent level under the Consumer Product Safety Act (see 16 CFR part 1303), paragraphs (i) and (ii) of § 1500.17(a)(6) are revoked as to the sub-ject products manufactured after Feb-ruary 27, 1978.

NOTE: The effective date of paragraphs (a)(6)(i)(A) and (a)(6)(ii)(A) was stayed by an order published in the FEDERAL REGISTER of August 10, 1972 (37 FR 16078).

(7) General-use garments containing asbestos (other than garments having a bona fide application for personal pro-tection against thermal injury and so constructed that the asbestos fibers will not become airborne under reason-ably foreseeable conditions of use).

(8) Firecrackers designed to produce audible effects, if the audible effect is produced by a charge of more than 50 milligrams (.772 grains) of pyrotechnic composition (not including fire-crackers included as components of a rocket), aerial bombs, and devices that may be confused with candy or other foods, such as ‘‘dragon eggs,’’ and ‘‘cracker balls’’ (also known as ‘‘ball- type caps’’), and including kits and components intended to produce such fireworks except such devices which meet all of the following conditions:

(i) The fireworks devices are distrib-uted to farmers, ranchers, or growers through a wildlife management pro-gram administered by the U.S. Depart-ment of Interior (or by equivalent State or local governmental agencies); and

(ii) Such distribution is in response to a written application describing the wildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and is where other means of control is un-available or inadequate. (See also § 1500.17(a) (3) and (9)).

(9) All fireworks devices, other than firecrackers, including kits and compo-nents intended to produce such fire-works, not otherwise banned under the act, that do not comply with the appli-cable requirements of part 1507 of this

chapter, except fireworks devices which meet all the following condi-tions:

(i) The fireworks devices are distrib-uted to farmers, ranchers, or growers through a wildlife management pro-gram administered by the U.S. Depart-ment of the Interior (or by equivalent State or local government agencies); and

(ii) Such distribution is in response to a written application describing the wildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and is where other means of control is un-available or inadequate. (See also § 1500.17(a) (3) and (8)).

(10) Self-pressurized products in-tended or suitable for household use that contain vinyl chloride monomer as an ingredient or in the propellant manufactured or imported on or after October 7, 1974. (See also § 1500.17(a) (3) and (8)).

(11)(i) Reloadable tube aerial shell fireworks devices that use shells larger than 1.75 inches in outer diameter and that are imported on or after October 8, 1991.

(ii) Findings. (A) General. In order to issue a rule under section 2(q)(1) of the Federal Hazardous Substances Act (‘‘FHSA’’), 15 U.S.C. 1261(q)(1), classifying a substance or article as a banned hazardous substance, the FHSA requires the Commission to make cer-tain findings and to include these find-ings in the regulation. These findings are discussed below.

(B) Voluntary standard. Although a voluntary standard relating to the risk of injury associated with reloadable tube aerial shells has been adopted, it has not been implemented. Thus, the Commission is not required to make findings covering the likelihood that the voluntary standard would result in elimination or adequate reduction of the risk of injury or that there would be substantial compliance with the vol-untary standard.

(C) Relationship of benefits to costs. The Commission estimates that the re-moval of large reloadable shells from the market is likely to virtually elimi-nate the number of associated injuries, with only a slight offsetting increase in


441


the number of injuries due to the use of substitute Class C fireworks products available to consumers. The estimated net benefits range from essentially zero to close to $1 million annually. The an-nual costs of a ban are estimated to be very low. Included are potential costs to foreign manufacturers and U.S. im-porters from sales losses, production changes, and inventory retrofitting, and slightly reduced market choices for consumers who purchase aerial dis-play fireworks. Costs to each of these sectors are estimated to be slight, and are reduced to the extent that alter-native products are perceived as ade-quate substitutes for large reloadable shells. Thus, the Commission finds that the benefits expected from the regula-tion bear a reasonable relationship to its costs.

(D) Least burdensome requirement. The Commission considered several alter-natives to the ban. These included: De-sign or performance criteria; addi-tional or alternative labeling; inclu-sion of some reloadable shells 1.75 inches or smaller in the ban; and no ac-tion in reliance on the voluntary standard. The Commission determined that a ban of reloadable shells larger than 1.75 inches in outer diameter is the least burdensome alternative that would prevent or adequately reduce the risk of injury.

(1) Regarding design or performance criteria, the Commission considered re-quirements similar to those stated in the voluntary standard of the Amer-ican Fireworks Standards Laboratory (‘‘AFSL’’). However, such criteria may increase the cost of the product and would not address all factors involved in the incidents. Further, concerns exist about the feasibility of criteria and quality control.

(2) Regarding additional or alter-native labeling, the users’ perception and experience concerning the amount of time available to get away may lead them to disregard an inconsistent warning. There are no data to suggest that a significant number, if any, inci-dents would be avoided if large reloadable shells carried more detailed labels or instructions than they cur-rently do. It cannot be concluded that potential benefits would be greater than zero.

(3) The Commission considered in-cluding reloadable shells that are 1.75 inches or less in outer diameter and have the ‘‘equivalent explosive power’’ of larger shells. A kinetic energy level of 70 joules was considered to evaluate explosive power. However, any poten-tial benefits are uncertain since the Commission concluded that a clear re-lation between kinetic energy and in-jury potential could not be established. Also, costs could be slightly higher.

(4) The Commission also considered imposing no mandatory requirements on large reloadable shells and relying instead on the AFSL voluntary stand-ard. However, it is uncertain whether any net benefits to consumers would result from this alternative, since the level of injury reduction could be near zero if, as is probable, some firms chose not to conform with some or all of the AFSL standard.

(12)(i) Large multiple-tube devices. Mul-tiple-tube mine and shell fireworks de-vices that first enter commerce or are imported on or after March 26, 1997, that have any tube measuring 1.5 inches (3.8 cm) or more in inner diame-ter, and that have a minimum tip angle less than 60 degrees when tested in ac-cordance with the procedure of § 1507.12 of this part.

(ii) Findings—(A) General. In order to issue a rule under the section 2(q)(1) of the FHSA, 15 U.S.C. 1261(q)(1), classifying a substance or article as a banned hazardous substance, the FHSA requires the Commission to make cer-tain findings and to include these in the regulation. These findings are dis-cussed in paragraphs (a)(12)(ii) (B) through (D) of this section.

(B) Voluntary standard. (1) One alter-native to the tip-angle requirement that the Commission considered is to take no mandatory action, and to de-pend on a voluntary standard. The American Fireworks Safety Labora-tory (AFSL) has a standard for mines and shells intended to address the po-tential tip-over hazard associated with multiple-tube fireworks devices. AFSL’s Voluntary Standard for Mines and Shells—Single or Multiple Shot re-quires that large multiple-tube devices not tip over (except as the result of the last shot) when shot on a 2-inch thick


442

16 CFR Ch. II (1–1–10 Edition) § 1500.17

medium-density foam pad. The Com-mission cannot conclude that AFSL’s existing voluntary standard adequately reduces the risk of injury from large devices that tip over while functioning. The Commission’s tests using poly-urethane foam did not find sufficient agreement between performance on foam and on grass. No other data are available to show that this dynamic test is reliable.

(2) In addition, even if the AFSL standard is effective, the Commission does not believe that compliance with the standard will be adequate. AFSL reports that it has been testing in ac-cordance with its standard since Janu-ary 1994. However, the results of CPSC’s compliance testing indicate that multiple-tube devices still tip over while functioning. In fiscal year 1994, all 24 imported devices the Com-mission tested, and 1 of 8 domestic de-vices, tipped over while functioning. In fiscal year 1995, 22 of 27 imported de-vices and 1 of 5 domestic devices tipped over during Commission testing. The Commission finds that there is un-likely to be substantial compliance with the voluntary standard applicable to multiple-tube devices.

(C) Relationship of benefits to costs. The Commission estimates that the 60- degree tip-angle standard will elimi-nate the unreasonable tip-over risk posed by these devices. This will pro-vide benefits of saving one life about every 3 years, and preventing an un-known number of nonfatal injuries. The annual cost of modifying affected devices is estimated to be between $1.5 million and $2.7 million. The Commis-sion finds that the benefits from the regulation bear a reasonable relation-ship to its costs.

(D) Least burdensome requirement. The Commission considered the following alternatives: a ban of all multiple-tube devices with inner tube diameters 1.5 inches or greater; a dynamic perform-ance standard; additional labeling re-quirements; and relying on the vol-untary standard. Although a ban of all large multiple-tube devices would ad-dress the risk of injury, it would be more burdensome than the tip-angle standard. The Commission was unable to develop a satisfactory dynamic standard that would reduce the risk of

injury. Neither additional labeling re-quirements nor reliance on the vol-untary standard would adequately re-duce the risk of injury. Thus, the Com-mission finds that a standard requiring large multiple-tube devices to have a minimum tip angle greater than 60 de-grees is the least burdensome require-ment that would prevent or adequately reduce the risk of injury.

(13)(i) Candles made with metal-cored wicks. Candles manufactured or im-ported on or after October 15, 2003, made with metal-cored candlewicks, unless:

(A) The metal core of each candlewick has a lead content (cal-culated as the metal) of not more than 0.06 percent of the total weight of the metal core; and

(B) Each outer container or wrapper in which candles subject to paragraph (a)(13)(i)(A) of this section are shipped, including each outer container or wrapper in which such candles are dis-tributed to a retail outlet, is labeled ‘‘Conforms to 16 CFR 1500.17(a)(13).’’ For purposes of this paragraph (B), the term ‘‘outer container or wrapper’’ does not include the immediate con-tainer in which candle(s) is/are in-tended to be displayed at retail or dur-ing use in the home, unless that con-tainer or wrapper is also the only con-tainer or wrapper in which the can-dle(s) is/are shipped to a retailer.

(ii) Metal-cored candlewicks. Metal- cored candlewicks manufactured or im-ported on or after October 15, 2003, un-less:

(A) The metal core of each candlewick has a lead content (cal-culated as the metal) of not more than 0.06 percent of the total weight of the metal core; and

(B) Each outer container or wrapper in which candlewicks subject to para-graph (a)(13)(ii)(A) of this section is shipped, including each outer container or wrapper of a shipment distributed to a retail outlet, is labeled ‘‘Conforms to 16 CFR 1500.17(a)(13).’’ For purposes of this paragraph (B), the term ‘‘outer container or wrapper’’ does not include the immediate container in which candlewick(s) is/are intended to be dis-played or sold at retail, unless that container or wrapper is also the only container or wrapper in which the


443


candlewick(s) is/are shipped to a re-tailer.

(iii) Findings—(A) General. To issue a rule under section 2(q)(1) of the FHSA, 15 U.S.C. 1261(q)(1), classifying a sub-stance or article as a banned hazardous substance, the Commission must make certain findings and include them in the regulation. These findings are dis-cussed in paragraphs (a)(13)(iii)(B) through (D) of this section.

(B) Voluntary Standard. One alter-native to the ban that the Commission considered is to take no mandatory ac-tion, and to depend on a voluntary standard. One organization has a standard for candlewicks intended to address the potential for substantial illness posed by such wicks and candles with such wicks. The Commission has found that the standard is technically unsound and that substantial compli-ance with it is unlikely. Furthermore, there is no evidence that the standard has been adopted and implemented by candlewick or candle manufacturers.

(C) Relationship of Benefits to Costs. The Commission estimates that the ban will reduce the potential for expo-sure to lead and resulting lead poi-soning because there is no ‘‘safe’’ level of lead in the blood. The annual cost to the candle/wick industry of the ban is estimated by the Commission to be in the range of $100,000 to $300,000. On a percentage basis these costs represent only 0.005 to 0.015 percent of the overall value of candle shipments in 2000, which was approximately $2 billion. Accordingly, the Commission finds that the benefits from the regulation bear a reasonable relationship to its costs.

(D) Least burdensome requirement. The Commission considered the following alternatives: no action; labeling all metal-cored candles with wicks con-taining more than 0.06 percent lead by weight of the metal; recordkeeping for shipments of wicks containing 0.06 per-cent or less lead by weight of the metal and of candles with such wicks; and re-lying on the voluntary standard. Nei-ther no action, nor labeling, nor reli-ance on the voluntary standard would adequately reduce the risk of illness. Recordkeeping for shipments of wicks and of candles was not the least bur-densome requirement that would pre-

vent or adequately reduce the risk of illness. Therefore the Commission finds that a ban on candlewicks containing more than 0.06 percent lead by weight of the metal and candles with such wicks is the least burdensome require-ment that would prevent or adequately reduce the risk of illness.

(b) [Reserved]

(Secs. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74 Stat. 372, 374, as amended 80 Stat. 1304–05, 83 Stat. 187–189, 90 Stat. 503 (15 U.S.C. 1261, 1262); sec. 701 (e), (f), (g), 52 Stat. 1055–56, as amended 70 Stat. 919, 72 Stat. 948 (21 U.S.C. 371 (e), (f), (g)), sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a)))

[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 27514, Oct. 4, 1973; 38 FR 31520, Nov. 15, 1973; 39 FR 30114, Aug. 21, 1974; 39 FR 42903, Dec. 9, 1974; 41 FR 22935, June 8, 1976; 42 FR 44202, Sept. 1, 1977; 43 FR 12310, Mar. 24, 1978; 48 FR 16, Jan. 3, 1983; 56 FR 37837, Aug. 9, 1991; 61 FR 13095, Mar. 26, 1996; 61 FR 18245, Apr. 25, 1996; 68 FR 19147, Apr. 18, 2003]

§ 1500.18 Banned toys and other banned articles intended for use by children.

(a) Toys and other articles presenting mechanical hazards. Under the author-ity of sections 2(f)(1)(D) and 24 of the act and pursuant to the provisions of section 3(e) of the act, the Commission has determined that the following types of toys or other articles intended for use by children present a mechan-ical hazard within the meaning of sec-tion 2(s) of the act because in normal use, or when subjected to reasonably foreseeable damage or abuse, the de-sign or manufacture presents an unrea-sonable risk of personal injury or ill-ness:

(1) Any toy rattle containing, either internally or externally, rigid wires, sharp protrusions, or loose small ob-jects that have the potential for caus-ing lacerations, puncture wound in-jury, aspiration, ingestion, or other in-jury. (But see § 1500.86(a)(1)).

(2) Any toy having noisemaking com-ponents or attachments capable of being dislodged by the operating fea-tures of the toy or capable of being de-liberately removed by a child, which toy has the potential for causing lac-eration, puncture wound injury, aspira-tion, ingestion, or other injury.

(3) Any doll, stuffed animal, or other similar toy having internal or external


444

16 CFR Ch. II (1–1–10 Edition) § 1500.18

components that have the potential for causing laceration, puncture wound in-jury, or other similar injury. (But see § 1500.86(a)(2)); (See also §§ 1500.48 and 1500.49).

(4) Lawn darts and other similar sharp-pointed toys usually intended for outdoor use and having the potential for causing puncture wound injury.

(5) Caps (paper or plastic) intended for use with toy guns and toy guns not intended for use with caps if such caps when so used or such toy guns produce impulse-type sound at a peak pressure level at or above 138 decibels, referred to 0.0002 dyne per square centimeter, when measured in an anechoic chamber at a distance of 25 centimeters (or the distance at which the sound source or-dinarily would be from the ear of the child using it if such distance is less than 25 centimeters) in any direction from the source of the sound. This paragraph is an interim regulation pending further investigation to deter-mine whether prevention of damage to the hearing of children requires revi-sion hereof.

(6) Any article known as a ‘‘baby- bouncer,’’ ‘‘walker-jumper,’’ or ‘‘baby- walker’’ and any other similar article (referred to in this paragraph as ‘‘arti-cle(s)’’) which is intended to support very young children while sitting walk-ing, bouncing, jumping, and/or reclin-ing, and which because of its design has any exposed parts capable of causing amputation, crushing, lacerations, fractures, hematomas, bruises, or other injuries to fingers, toes, or other parts of the anatomy of young children. In-cluded among, but not limited to, the design features of such articles which classify the articles as banned haz-ardous substances are:

(i) The areas about the point on each side of the article where the frame components are joined together to form an ‘‘X’’ shape capable of pro-ducing a scissoring, shearing, or pinch-ing effect.

(ii) Other areas where two or more parts are joined in such a manner as to permit a rotational movement capable of exerting a scissoring, shearing, or pinching effect.

(iii) Exposed coil springs which may expand sufficiently to allow an infant’s finger, toe, or any other part of the

anatomy to be inserted, in whole or in part, and injured by being caught be-tween the coils of the spring or be-tween the spring and another part of the article.

(iv) Holes in plates or tubes which provide the possibility of insertion, in whole or in part, of a finger, toe, or any part of the anatomy that could then be injured by the movement of another part of the article.

(v) Design and construction that per-mits accidental collapse while in use. (But see § 1500.86(a)(4)).

(7) Toys usually known as clacker balls and consisting of two balls of plastic or another material connected by a length of line or cord or similar connector (referred to as ‘‘cord’’ in § 1500.86(a)(5)), intended to be operated in a rhythmic manner by an upward and downward motion of the hand so that the two balls will meet forcefully at the top and bottom of two semicircles thus causing a ‘‘clacking’’ sound, which toys present a mechan-ical hazard because their design or manufacture presents an unreasonable risk of personal injury from fracture, fragmentations, or disassembly of the toy and from propulsion of the toy or its part(s). (But see § 1500.86(a)(5).) This does not include products that are con-structed so that the connecting mem-bers consist of plastic rods integrally molded to the balls and are mounted on a pivot so that movement of the balls is essentially limited to a single plane.

(8) Any pacifier that does not meet the requirements of 16 CFR part 1511 and that is introduced into interstate commerce after February 26, 1978.

(9) Any toy or other article intended for use by children under 3 years of age which presents a choking, aspiration, or ingestion hazard because of small parts as determined by part 1501 of this chapter and which is introduced into interstate commerce after January 1, 1980. For purposes of this regulation, introduction into interstate commerce is defined as follows: A toy or chil-dren’s article manufactured outside the United States is introduced into inter-state commerce when it is first brought within a U.S. port of entry. A toy or children’s article manufactured in the United States is introduced into interstate commerce (1) at the time of


445


its first interstate sale, or (2) at the time of its first intrastate sale if one or more of its components and/or raw ma-terials were received interstate, which-ever occurs earlier. Part 1501 defines the term ‘‘toy or other article intended for use by children under 3,’’ as used in this regulation, and exempts certain products from banning under this regu-lation.

(10)–(11) [Reserved] (12) Any bicycle as defined in

§ 1512.2(a) of this chapter (except a bicy-cle that is a ‘‘track bicycle’’ or a ‘‘one- of-a-kind bicycle’’ as defined in § 1512.2 (d) and (e) of this chapter) that is in-troduced into interstate commerce on or after May 11, 1976, and that does not comply with the requirements of part 1512 of this chapter, except for §§ 1512.5(c)(3), 1512.9(a), 1512.18(e) and 1512.18(f) which become effective No-vember 13, 1976.

(13) Any full-size baby crib (as de-fined in § 1508.1(a) of this chapter) that is introduced into interstate commerce on or after February 1, 1974, and that does not comply with the requirements of §§ 1508.2 through 1508.10 of this chap-ter; and any full size baby crib (as de-fined in § 1508.1(a) of this chapter) that is manufactured on or after April 27, 1983, and that does not comply with §§ 1508.2 through 1508.11 of this chapter.

(14) Any non-full-size baby crib (as defined in § 1509.2 of this chapter) that is introduced into interstate commerce after August 9, 1976, and that does not comply with the requirements of §§ 1509.3 through 1509.12 of this chapter; and any non-full size baby crib (as de-fined in § 1509.2 of this chapter) that is manufactured on or after April 27, 1983, and that does not comply with §§ 1509.3 through 1509.13 of this chapter.

(15) Any rattle (as defined in § 1510.2 of this chapter) that is introduced into interstate commerce on or after Au-gust 21, 1978, and that does not comply with the requirements of part 1510 of this chapter. For purposes of the regu-lation, introduction into interstate commerce is defined as follows: A rat-tle manufactured outside the United States is introduced into interstate commerce when it is first brought within a U.S. port of entry. A rattle manufactured in the United States is introduced into interstate commerce

(a) at the time of its first interstate sale, or (b) at the time of its first intra-state sale if one or more of its compo-nents and/or raw materials were re-ceived interstate.

(16) (i) Any article known as an ‘‘in-fant cushion’’ or ‘‘infant pillow,’’ and any other similar article, which has all of the following characteristics (But see § 1500.86(a)(9)):

(A) Has a flexible fabric covering. The term fabric includes those mate-rials covered by the definition of ‘‘fab-ric’’ in section 2(f) of the Flammable Fabrics Act, 15 U.S.C. 1191(f).

(B) Is loosely filled with a granular material, including but not limited to, polystyrene beads or pellets.

(C) Is easily flattened. (D) Is capable of conforming to the

body or face of an infant. (E) Is intended or promoted for use

by children under one year of age. (ii) Findings—(A) General. In order to

issue a rule under section 2(q)(1) of the Federal Hazardous Substance Act (FHSA), 15 U.S.C. 1261(q)(1), classifying a substance or article as a banned haz-ardous substance, the FHSA requires the Commission to make certain find-ings and to include these findings in the regulation. These findings are dis-cussed in paragraphs (a)(16)(ii) (B) through (D) of this section.

(B) Voluntary standard. No findings concerning compliance with or ade-quacy of a voluntary standard are nec-essary since no voluntary standard ad-dressing infant cushions has been adopted or implemented.

(C) Relationship of benefits to costs. The Commission estimates that the re-moval of infant cushions from the mar-ket will result in total annual benefits of approximately five million dollars. The potential costs to businesses are expected to be offset by production of other products, and the potential costs to consumers are likely to be offset by the availability of substitutes for a comparable price.

(D) Least burdensome requirement. The Commission considered labeling and a design or performance standard as al-ternatives to the ban. The Commission does not believe that any form of label-ing would have a significant effect in preventing the hazard associated with infant cushions. The Commission also


446

16 CFR Ch. II (1–1–10 Edition) § 1500.18

concluded that no feasible standard ex-ists that would address the hazard. Thus, the Commission determined that a ban of infant cushions is the least burdensome alternative that would prevent or adequately reduce the risk of injury.

(17) Any ball intended for children under three years of age that, under the influence of its own weight, passes, in any orientation, entirely through a circular hole with a diameter of 1.75 inches (44.4 mm.) in a rigid template 1⁄4 inches (6 mm.) thick. In testing to evaluate compliance with this para-graph, the diameter of opening in the Commission’s test template shall be no greater than 1.75 inches (44.4 mm.).

(i) For the purposes of this para-graph, the term ‘‘ball’’ includes any spherical, ovoid, or ellipsoidal object that is designed or intended to be thrown, hit, kicked, rolled, dropped, or bounced. The term ‘‘ball’’ includes any spherical, ovoid, or ellipsoidal object that is attached to a toy or article by means of a string, elastic cord, or simi-lar tether. The term ‘‘ball’’ also in-cludes any multi-sided object formed by connecting planes into a generally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball, and any novelty item of a generally spherical, ovoid, or ellip-soidal shape that is designated or in-tended to be used as a ball.

(ii) The term ‘‘ball’’ does not include dice, or balls permanently enclosed in-side pinball machines, mazes, or simi-lar outer containers. A ball is perma-nently enclosed if, when tested in ac-cordance with 16 CFR 1500.52, the ball is not removed from the outer con-tainer.

(iii) In determining whether such a ball is intended for use by children under three years of age, the criteria specified in 16 CFR 1501.2(b) and the en-forcement procedure established by 16 CFR 1501.5 shall apply.

(18)(i) Any bunk bed (as defined in § 1513.2(c) of this chapter) that does not comply with the requirements of part 1513 of this chapter.

(ii) Findings. In order to issue a rule under Section 3(e) of the Federal Haz-ardous Substances Act (FHSA), 15 U.S.C. 1262(e), classifying a toy or other article intended for use by chil-

dren as a hazardous substance on the basis that it presents a mechanical hazard (as defined in Section 2(s) of the FHSA), the FHSA requires the Com-mission to make the following findings and to include these findings in the regulation: Bunk beds present a me-chanical hazard; Where a voluntary standard has been adopted and imple-mented by the affected industry, that compliance with such voluntary stand-ard is not likely to result in the elimi-nation or adequate reduction of the risk of injury, or it is unlikely that there will be substantial compliance with such voluntary standard; The ben-efits expected from the rule bear a rea-sonable relationship to its costs; and The rule imposes the least burdensome requirement that prevents or ade-quately reduces the risk of injury for which the rule is being promulgated. These findings are made in the appen-dix to Part 1513.

(19)(i) Dive sticks, and other similar articles, that are used in swimming pools or other water environments for such activities as underwater retrieval games or swimming instruction, and which, when placed in the water, sub-merge and rest at the bottom of the pool. This includes products that are pre-weighted to sink to the bottom and products that are designed to allow the user to adjust the weight. Dive sticks and similar articles that come to rest underwater at an angle greater than 45 degrees from vertical when measured under the test at § 1500.86(a)(7) and dive sticks and similar articles that main-tain a compressive force of less than 5- lbf under the test at § 1500.86(a)(8) are exempt from this banning rule. Arti-cles that have a continuous circular shape, such as dive rings and dive disks are also exempt.

(ii)(A) Findings. In order for the Com-mission to issue a rule under section 2(q)(1) of the FHSA classifying a sub-stance or article as a banned hazardous substance, the Commission must make certain findings and include these find-ings in the regulation. 15 U.S.C. 1262(i)(2). These findings are discussed in paragraphs (a)(18)(ii)(B) through (D) of this section.


447


(B) Voluntary standard. No findings concerning compliance with and ade-quacy of a voluntary standard are nec-essary because no relevant voluntary standard addressing the risk of injury posed by dive sticks has been adopted and implemented.

(C) Relationship of benefits to costs. The Commission estimates the poten-tial benefits of removing hazardous dive sticks from the market to be 2 to 4 cents per dive stick. With the avail-ability of substitutes and the expected low cost of modifying dive sticks to conform to the rule, the Commission anticipates that necessary changes will be minimal. The Commission estimates that the costs of the rule will be no more than 2 to 4 cents per dive stick. Thus, the Commission finds that there is a reasonable relationship between the expected benefits of the rule and its costs.

(D) Least burdensome requirement. The Commission considered pursuing vol-untary recalls, following a voluntary standard, requiring labeling or chang-ing the scope of the rule. A banning rule would be more effective than case- by-case recalls because the impalement hazard affects all dive sticks, not a spe-cific brand or model. Awaiting recalls would allow these hazardous items on the market until the Commission ob-tained recalls. No applicable voluntary standard exists, and compliance may be low if one did. Although labeling could help reduce the risk of injuries from dive sticks, it would be less effec-tive than a banning rule. It may be dif-ficult for a label to convey the nec-essary information at the time of use. Modifying the scope so that the rule would only apply to pre-weighted dive sticks would continue to permit haz-ardous items because the unweighted dive sticks can easily be weighted to stand vertically at the bottom of the water. Thus, the Commission finds that a ban of dive sticks with the hazardous characteristics it has identified is the least burdensome alternative that would adequately reduce the risk of in-jury.

(b) Electrically operated toys and other electrical operated children’s articles pre-senting electrical, thermal, and/or certain mechanical hazards. Under the author-ity of section 2(f)(1)(D) of the act and

pursuant to provisions of section 3(e) of the act, the Commission has deter-mined that the following types of elec-trically operated toys or other elec-trically operated articles intended for use by children present electrical, ther-mal, and/or certain mechanical hazards within the meaning of section 2 (r), (s), and/or (t) of the act because in normal use or when subjected to reasonably foreseeable damage or abuse, the de-sign or manufacture may cause per-sonal injury or illness by electric shock and/or presents an unreasonable risk of personal injury or illness because of heat as from heated parts, substances, or surfaces, or because of certain me-chanical hazards.

(1) Any electrically operated toy or other electrically operated article in-tended for use by children (as defined in § 1505.1(a)(1)) that is introduced into interstate commerce and which does not comply with the requirements of part 1505 of this chapter.

NOTE: Paragraph (b)(1) was originally pro-mulgated as 21 CFR 191.9a(b)(1) with an effec-tive date of September 3, 1973 (38 FR 6138).

(2) [Reserved] (c) Toys and other articles (not elec-

trically operated) presenting electric haz-ards. Under the authority of section 2(f)(1)(D) of the act and pursuant to provisions of section 3(e) of the act, the Commission has determined that the following types of toys or other arti-cles intended for use by children (not electrically operated) present an elec-trical hazard within the meaning of section 2(r) of the act.

(1) Any kite 10 inches or greater in any dimension constructed of alu-minized polyester film or any kite hav-ing a tail or other component con-sisting of a piece of aluminized poly-ester film 10 inches or greater in any dimension presents an electrical hazard and is a banned hazardous substance because its design (specifically its size and electrical conductivity) presents a risk of personal injury from electric shock due to its ability to conduct electricity and to become entangled in or otherwise contact high voltage elec-tric power lines.


448

16 CFR Ch. II (1–1–10 Edition) § 1500.19

(2) [Reserved]

(15 U.S.C. 1261 (f)(1)(D), (g)(1)(A), (r); 15 U.S.C. 1262(e)(1); 15 U.S.C. 2079(a))

[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 30105, Nov. 1, 1973; 38 FR 32132, Nov. 21, 1973; 41 FR 4144, Jan. 28, 1976; 41 FR 6240, Feb. 12, 1976; 42 FR 36823, July 18, 1977; 42 FR 61594, Dec. 6, 1977; 43 FR 22005, May 23, 1978; 44 FR 34903, June 15, 1979; 44 FR 55819, Sept. 28, 1979; 48 FR 16, Jan. 3, 1983; 48 FR 57268, Dec. 29, 1983; 53 FR 46839, Nov. 18, 1988; 57 FR 27915, June 23, 1992; 59 FR 9076, Feb. 25, 1994; 60 FR 10752, Feb. 27, 1995; 64 FR 71907, Dec. 22, 1999; 66 FR 13650, Mar. 7, 2001; 73 FR 77495, Dec. 19, 2008]

§ 1500.19 Misbranded toys and other articles intended for use by chil-dren.

(a) Definitions. For the purposes of this section, the following definitions shall apply.

(1) Ball means a spherical, ovoid, or ellipsoidal object that is designed or intended to be thrown, hit, kicked, rolled, dropped, or bounced. The term ‘‘ball’’ includes any spherical, ovoid, or ellipsoidal object that is attached to a toy or article by means of a string, elastic cord, or similar tether. The term ‘‘ball’’ also includes any multi- sided object formed by connecting planes into a generally, spherical, ovoid, or ellipsoidal shape that is des-ignated or intended to be used as a ball, and any novelty item of a gen-erally spherical, ovoid, or ellipsoidal shape that is designated or intended to be used as a ball. The term ‘‘ball’’ does not include dice, or balls permanently enclosed inside pinball machines, mazes, or similar outer containers. A ball is permanently enclosed if, when tested in accordance with 16 CFR 1500.53, it is not removed from the outer container.

(2) Small ball means a ball that, under the influence of its own weight, passes, in any orientation, entirely through a circular hole with a diameter of 1.75 inches (44.4 mm.) in a rigid template 1⁄4 inches (6 mm.) thick. In testing to evaluate compliance with this regula-tion, the diameter of opening in the Commission’s test template shall be no greater than 1.75 inches (44.4 mm.).

(3) Latex balloon means a toy or deco-rative item consisting of a latex bag that is designed to be inflated by air or gas. The term does not include inflat-

able children’s toys that are used in aquatic activities such as rafts, water wings, swim rings, or other similar items.

(4) Marble means a ball made of a hard material, such as glass, agate, marble or plastic, that is used in var-ious children’s games, generally as a playing piece or marker. The term ‘‘marble’’ does not include a marble permanently enclosed in a toy or game. A marble is permanently enclosed if, when tested in accordance with 16 CFR 1500.53, it is not removed from the toy or game.

(5) Small part means any object which, when tested in accordance with the procedures contained in 16 CFR 1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in Figure 1 appended to 16 CFR part 1501. The use and abuse testing provisions of 16 CFR 1500.51 through 1500.53 and 1501.4(b)(2) do not apply to this definition.

(6) Package or packaging refers to the immediate package in which a product subject to labeling under section 24 of the act is sold, as well as to any outer container or wrapping for that pack-age.

(7) Descriptive material means any dis-crete piece of written material sepa-rate from the label of the package that contains an instruction (whether writ-ten or otherwise) for the use of a prod-uct subject to these labeling require-ments, any depiction of the product, and any written material that specifi-cally describes any function, use, warn-ings, user population, design or mate-rial specification, or other char-acteristic of the product. A catalog or other marketing material or advertise-ment that depicts other products in ad-dition to the product it accompanies is not ‘‘descriptive material’’ unless it contains additional information, such as instructions for use of the product it accompanies or lists of accessories ex-clusively for use with that product, that are designed to focus the pur-chaser’s attention on the product. De-scriptive material ‘‘accompanies’’ a product subject to the labeling require-ments when it is packaged with the product or when it is intended to be distributed with the product at the time of sale or delivery to the pur-chaser. ‘‘Descriptive material’’ does


449


not include statements that appear on the package of a product subject to the labeling requirements. ‘‘Descriptive material’’ does not include material in-tended solely for use by children if the package it accompanies contains a sep-arate package insert prominently iden-tified as a warning for parents that contains the required precautionary statements.

(8) Bin and container for retail display mean containers in which multiple unpackaged and unlabeled items are held for direct selection by and sale to consumers.

(b) Misbranded toys and children’s arti-cles. Pursuant to sections 2(p) and 24 of the FHSA, the following articles are misbranded hazardous substances if their packaging, any descriptive mate-rial that accompanies them, and, if unpackaged and unlabeled, any bin in which they are held for sale, any con-tainer in which they are held for retail

display, or any vending machine from which they are dispensed, fails to bear the labeling statements required in paragraphs (b) (1) through (4) and para-graph (f)(3) of this section, or if such labeling statements fail to comply with the prominence and conspicuous-ness requirements of paragraph (d) of this section.

(1) With the exception of books and other articles made of paper, writing materials such as crayons, chalk, pen-cils, and pens, modeling clay and simi-lar products, fingerpaints, watercolors, and other paint sets, and any other ar-ticle identified in 16 CFR 1501.3 (other than balloons), any article that is a toy or game intended for use by children who are at least three years old but less than six years of age shall bear or contain the following cautionary state-ment if the toy or game includes a small part:

(2) Any latex balloon, or toy or game that contains a latex balloon, shall

bear the following cautionary state-ment:

(3)(i) Any small ball intended for children three years of age or older

shall bear the following cautionary statement:


27F

E95

.001

</G

PH

>E

R27

FE

95.0

02<

/GP

H>

450

16 CFR Ch. II (1–1–10 Edition) § 1500.19

(ii) Any toy or game intended for children who are at least three years old but less than eight years of age

that contains a small ball shall bear the following cautionary statement:

(4)(i) Any marble intended for chil-dren three years of age or older shall

bear the following cautionary state-ment:

(ii) Any toy or game intended for children who are at least three years old but less than eight years of age

that contains a marble shall bear the following cautionary statement:

(c) Age of intended user. In deter-mining the ages of the children for

which any toy or article subject to this


27F

E95

.003

</G

PH

>E

R27

FE

95.0

04<

/GP

H>

ER

27F

E95

.005

</G

PH

>E

R27

FE

95.0

06<

/GP

H>

451


section is intended, the following fac-tors are relevant: the manufacturer’s stated intent (such as the age stated on a label) if it is reasonable; the adver-tising, marketing, and promotion of the article; and whether the article is commonly recognized as being in-tended for children in this age group. In enforcing this provision, the Com-mission will follow the procedures set forth in 16 CFR 1501.5.

(d) Prominence and conspicuousness of labeling statements. The requirements of 16 CFR 1500.121 relating to the promi-nence and conspicuousness of pre-cautionary labeling statements for haz-ardous substances shall apply to any labeling statement required under § 1500.19(b) and (f), with the following clarifications and modifications.

(1) All labeling statements required by § 1500.19(b) and (f) shall be in the English language. The statements re-quired by paragraph (b) need not ap-pear in the format and layout depicted in paragraph (b). The statements re-quired by 16 CFR 1500.19(b) and (f) shall be blocked together within a square or rectangular area, with or without a border. This means that the state-ments must appear on at least two lines. The statements shall be sepa-rated from all other graphic material by a space no smaller than the min-imum allowable height of the type size for other cautionary material (e.g., the phrase ‘‘Not for children under 3 yrs.’’). If not separated by that distance, the labeling statements must be sur-rounded by a border line. Label design, the use of vignettes, or the proximity of other labeling or lettering shall not obscure or render inconspicuous any la-beling statement required under § 1500.19(b) and (f). This means that such statements shall appear on a solid background, which need not differ from the background color or any other color on the package label.

(2) The words ‘‘WARNING’’ or ‘‘SAFETY WARNING’’ required by sec-tion 24 of the FHSA shall be regarded as signal words.

(3) The statement ‘‘CHOKING HAZ-ARD’’ shall be regarded as a statement of the principal hazard associated with the products subject to this section.

(4) All other remaining statements required by this section shall be re-

garded as ‘‘other cautionary material’’ as that term is defined in 16 CFR 1500.121(a)(2)(viii).

(5) The principal display panel for a bin, container for retail display, or vending machine shall be the side or surface designed to be most promi-nently displayed, shown, or presented to, or examined by, prospective pur-chasers. In the case of bins or con-tainers for retail display, the cau-tionary material may be placed on a display card of a reasonable size in re-lationship to the surface area of the bin or container. The area of the dis-play card shall constitute the area of the principal display panel. In the case of vending machines that contain a dis-play card, the cautionary label may be placed either on the display card, on the coinage indicator decal, or on the glass or clear plastic of the machine. If there is no display card inside a vend-ing machine, the size of the principal display panel will be calculated in ac-cordance with 16 CFR 1500.121(c) based on the size of the front of the container from which items are dispensed, exclu-sive of the area of metal attachments, coin inserts, bases, etc. Any other side or surface of such a bin, container for retail sale, or vending machine that bears information, such as price or product description, for examination by purchasers shall be deemed to be a principal display panel, excluding any side or surface with information that only identifies the company that owns or operates a vending machine.

(6) All of the labeling statements re-quired by this section, including those classified as ‘‘other cautionary mate-rial,’’ must appear on the principal dis-play panel of the product, except as provided for by § 1500.19(f). Any signal word shall appear on the same line and in close proximity to the triangle re-quired by section 24 of the act. Mul-tiple messages should be provided with sufficient space between them, when feasible, to prevent them from visually blending together.

(7) All labeling statements required by this section shall comply with the following type size requirements. 16 CFR 1500.121(c)(1) explains how to com-pute the area of the principal display panel and letter height.


452

16 CFR Ch. II (1–1–10 Edition) § 1500.19

Area sq. in ........................................ 0–2 +2–5 +5–10 +10–15 +15–30 +30–100 +100–400 +400 Type Size ......................................... ......... ......... ......... .......... .......... ............ ............. .......Sig. Wd ............................................. 3⁄64″ 1⁄16″ 3⁄32″ 7⁄64″ 1⁄8″ 5⁄32″ 1⁄4″ 1⁄2″ St. Haz ............................................. 3⁄64″ 3⁄64″ 1⁄16″ 3⁄32″ 3⁄32″ 7⁄64″ 5⁄32″ 1⁄4″ Oth. Mat ........................................... 1⁄32″ 3⁄64″ 1⁄16″ 1⁄16″ 5⁄64″ 3⁄32″ 7⁄64″ 5⁄32″

(8) Labeling required by this section that appears on a bin, container for re-tail display, or vending machine shall be in reasonable proximity to any pric-ing or product information contained on the principal display panel, or, if such information is not present, in close proximity to the article that is subject to the labeling requirements.

(9) Descriptive material that accom-panies a product subject to the labeling requirements, including accompanying material subject to the alternative al-lowed by § 1500.19(f), shall comply with the requirements of 16 CFR 1500.121(c)(6) relating to literature con-taining instructions for use which ac-companies a hazardous substance. If the descriptive material contains in-structions for use, the required pre-cautionary labeling shall be in reason-able proximity to such instructions or directions and shall be placed together within the same general area (see 16 CFR 1500.121(c)(6)).

(10) In the case of any alternative la-beling statement permitted under § 1500.19(e), the requirements of 16 CFR 1500.121(b)(3) and 1500.121(c)(2)(iii) shall apply to statements or indicators on the principal display panel directing attention to the complete cautionary labeling that appears on another dis-play panel.

(11) Any triangle required by this sec-tion shall be an equilateral triangle. The height of such a triangle shall be equal to or exceed the height of the let-ters of the signal word ‘‘WARNING’’. The height of the exclamation point in-side the triangle shall be at least half the height of the triangle, and the ex-clamation point shall be centered vertically in the triangle. The triangle

shall be separated from the signal word by a distance at least equal to the space occupied by the first letter of the signal word. In all other respects, tri-angles with exclamation points shall conform generally to the provisions of 16 CFR 1500.121 relating to signal words.

(e) Combination of labeling statements. The labels of products that contain more than one item subject to the re-quirements of this section may com-bine information relating to each of the respective hazards, if the resulting condensed statement contains all of the information necessary to describe the hazard presented by each article. However, in the case of a product that contains a balloon and another item subject to the labeling requirements, only the signal word and statement of hazard may be combined.

(f) Alternative labeling statements for small packages. Any cautionary state-ment required by section 1500.19(b) may be displayed on a display panel of the package of a product subject to the la-beling requirement other than the principal display panel only if:

(1) The package has a principal dis-play panel of 15 square inches or less,

(2) The full labeling statement re-quired by paragraph (b) of this section is displayed in three or more languages on another display panel of the pack-age of the product, and

(3)(i) In the case of a toy or game subject to § 1500.19(b)(1), a small ball subject to § 1500.19(b)(3), a marble sub-ject to § 1500.19(b)(4), or a toy or game containing such a ball or marble, the principal display panel of the package bears the statement:


27F

E95

.007

</G

PH

>

453


and bears an arrow or other indicator pointing toward or directing the pur-chaser’s attention to the display panel on the package where the full labeling statement appears, or

(ii) In the case of a balloon subject to § 1500.19(b)(2) or a toy or game con-taining such a balloon, the principal display panel bears the statement:

and bears an arrow or other indicator pointing toward or directing the pur-chaser’s attention to the display panel on the package where the full labeling statement appears.

(g) Alternative for products manufac-tured outside the United States. In the case of a product subject to the label-ing requirements of § 1500.19(b) which is manufactured outside the United States and is shipped directly from the manufacturer to the consumer by United States mail or other delivery service in an immediate package that contains descriptive material, the de-scriptive material inside the imme-diate package of the product need not bear the required labeling statement only if the shipping container of the product contains other accompanying material that bears the required state-ments displayed in a prominent and conspicuous manner. Products shipped from abroad to a U.S. affiliate for ship-ment to consumers are included within the scope of this exception.

(h) Preemption. Section 101(e) of the Child Safety Protection Act of 1994 pro-hibits any state or political subdivision of a state from enacting or enforcing any requirement relating to cautionary labeling addressing small parts hazards or choking hazards associated with any toy, game, marble, small ball, or bal-loon intended or suitable for use by children unless the state or local re-quirement is identical to a require-ment established by section 24 of the FHSA or by 16 CFR 1500.19. Section 101(e) allows a state or political sub-division of a state to enforce a non- identical requirement relating to cau-tionary labeling warning of small parts hazards or choking hazards associated with any toy subject to the provisions of section 24 of FHSA until January 1,

1995, if the non-identical requirement was in effect on October 2, 1993.

[60 FR 10752, Feb. 27, 1995, as amended at 60 FR 41802, Aug. 14, 1995]

§ 1500.20 Labeling requirement for ad-vertising toys and games.

(a) Scope. This section applies to catalogue and other printed material advertisements which provide a direct means of purchase or order of products requiring cautionary labeling under sections 24(a) and (b) of the FHSA.

(b) Effective Date. Under the Con-sumer Product Safety Improvement Act of 2008, Public Law 110–314, 122 Stat. 3016 (August 14, 2008), (‘‘CPSIA’’), the effective date of the CPSIA’s amendment to Section 24 of the FHSA to require cautionary statements in catalogues and other printed materials is February 10, 2009. By this rule, the Commission is providing a grace period of 180 days, or until August 9, 2009, dur-ing which catalogues and other printed materials printed prior to February 10, 2009, may be distributed without such cautionary statements. Catalogues and other printed materials that are print-ed on or after February 10, 2009, must have the required cautionary state-ments. All catalogues and other print-ed materials distributed on or after Au-gust 9, 2009, must comply with this rule. This rule addresses only cata-logues and other printed materials; however, the CPSIA extends the re-quirements for cautionary statements to Internet advertisements as well. Internet advertisements must comply with Section 24 of the FHSA as amend-ed by the CPSIA no later than Decem-ber 12, 2008.


27F

E95

.008

</G

PH

>

454

16 CFR Ch. II (1–1–10 Edition) § 1500.20

(c) Definitions. For the purposes of this section, the following definitions shall apply.

(1) Ball means a spherical, ovoid, or ellipsoidal object that is designed or intended to be thrown, hit, kicked, rolled, dropped, or bounced. The term ‘‘ball’’ includes any spherical, ovoid, or ellipsoidal object that is attached to a toy or article by means of a string, elastic cord, or similar tether. The term ‘‘ball’’ also includes a multi-sided object formed by connecting planes into a generally spherical, ovoid, or el-lipsoidal shape that is designated or in-tended to be used as a ball, and any novelty item of a generally spherical, ovoid, or ellipsoidal shape that is des-ignated or intended to be used as a ball. The term ‘‘ball’’ does not include dice, or balls permanently enclosed in-side pinball machines, mazes, or simi-lar other containers. A ball is perma-nently enclosed if, when tested in ac-cordance with 16 CFR 1500.53, it is not removed from the outer container.

(2) Small ball means a ball that, under the influence of its own weight, passes in any orientation, entirely through a circular hole with a diameter of 1.75 inches (44.4 mm) in a rigid template 1⁄4 inches (6 mm) thick. In testing to evaluate compliance with this regula-tion, the diameter of opening in the Commission’s test template shall be no greater than 1.75 inches (44.4 mm).

(3) Latex balloon means a toy or deco-rative item consisting of a latex bag that is designed to be inflated by air or gas. The term does not include inflat-able children’s toys that are used in aquatic activities such as rafts, water wings, swim rings, or other similar items.

(4) Marble means a ball made of hard material, such as glass, agate, marble, or plastic, that is used in various chil-

dren’s games, generally as a playing piece or marker. The term ‘‘marble’’ does not include a marble permanently enclosed in a toy or game. A marble is permanently enclosed if, when tested in accordance with 16 CFR 1500.53, it is not removed from the toy or game.

(5) Small part means any object which, when tested in accordance with the procedures contained in 16 CFR 1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in Figure 1 appended to 16 CFR part 1501. The use and abuse testing provisions of 16 CFR 1500.51 through 1500.53 and 1501.4(b)(2) do not apply to this definition.

(6) Direct means of purchase or order means any method of purchase that al-lows the purchaser to order the product without being in the physical presence of the product. Advertising that pro-vides a direct means of purchase or order of a product would include cata-logues or other printed advertising ma-terial that contain order blanks, tele-phone numbers or fax numbers for plac-ing orders, and Internet Web sites that enable consumers to purchase a prod-uct online or through the use of a tele-phone number or fax number provided on the Internet Web site.

(d) Advertising requirements. Any toy or game that requires a cautionary statement about the choking hazard associated with small parts, balloons, small balls, or marbles must bear that cautionary statement in the product’s advertising if the advertising provides a direct means to purchase or order the product.

(1) The advertising for any article that is a toy or game intended for use by children who are at least three years old but less than six years of age shall bear or contain the following cau-tionary statement if the toy or game includes a small part:


455


(2) The advertising for any latex bal-loon, or toy or game that contains a

latex balloon, shall bear the following cautionary statement:

(3)(i) The advertising for any small ball intended for children three years

of age or older shall bear the following cautionary statement:


17N

O08

.093

</G

PH

>E

R17

NO

08.0

94<

/GP

H>

456

16 CFR Ch. II (1–1–10 Edition) § 1500.20

(ii) The advertising for any toy or game intended for children who are at least three years old but less than

eight years of age that contains a small ball shall bear the following cau-tionary statement:

(4)(i) The advertising for any marble intended for children three years of age

or older shall bear the following cau-tionary statement:

(ii) The advertising for any toy or game intended for children who are at least three years old but less than

eight years of age that contains a mar-ble shall bear the following cautionary statement:


17N

O08

.095

</G

PH

>E

R17

NO

08.0

96<

/GP

H>

ER

17N

O08

.097

</G

PH

>

457


(e) Abbreviated warnings for catalogues and other printed materials. Abbreviated versions of the required cautionary statements are permitted in each indi-vidual product advertisement, provided that the corresponding full cautionary statements appear in the catalogue and a statement referring to the precise lo-cation of the full cautionary state-ments—such as the page number on which the cautionary statements can be found—is located at the bottom of each catalogue page that contains one or more abbreviated cautionary state-ments. If abbreviated cautionary state-ments are used:

(1) The full cautionary statements associated with the abbreviated cau-tionary statements shall appear:

(i) Near the beginning of the cata-logue, before any catalogue pages that contain advertisements of products available for purchase, or

(ii) Adjacent to the ordering informa-tion or order form in the catalogue.

(2) The full cautionary statements shall be in conspicuous and legible type in contrast by typography, layout or color.

(3) The full cautionary statements shall be clearly numbered according to the following scheme:

Required cautionary statement Number

16 CFR 1500.19(b)(1) 1 ................................. 1 16 CFR 1500.19(b)(2) 2 ................................. 2 16 CFR 1500.19(b)(3)(i) 3 .............................. 3 16 CFR 1500.19(b)(3)(ii) 4 ............................. 4 16 CFR 1500.19(b)(4)(i) 5 .............................. 5 16 CFR 1500.19(b)(4)(ii) 6 ............................. 6

1 See figure 1. 2 See Figure 2. 3 See Figure 3. 4 See Figure 4. 5 See Figure 5. 6 See Figure 6.

(4) The abbreviated cautionary state-ments shall consist of items 1500.20(e)(3)(i) through 1500.20(e)(3)(iv):

(i) A safety alert symbol substan-tially similar to that shown in figure 7.

(ii) The phrase, ‘‘CHOKING HAZ-ARD,’’ written in capital letters.

(iii) Numbers, separated by commas and enclosed within a single set of pa-rentheses, that identify the applicable cautionary statements for the product

being advertised, followed by a period. These numbers shall match the num-bers used to identify each full cau-tionary statement, as specified in 1500.20(e)(2).


17N

O08

.098

</G

PH

>E

R17

NO

08.0

99<

/GP

H>

458

16 CFR Ch. II (1–1–10 Edition) § 1500.40

(iv) A single prohibited age range written as either ‘‘Not for under 3 yrs’’ or ‘‘Not for under 8 yrs,’’ based on the most restrictive age range for all re-quired cautionary statements for that product. Thus, if an advertised product requires the cautionary statement specified in 16 CFR 1500.19(b)(2), the prohibited age range in the abbreviated

cautionary statement shall be ‘‘Not for under 8 yrs.’’

(v) For example, see Figure 8 for the abbreviated cautionary statement for an advertisement of a product that re-quires the cautionary statements spec-ified in 16 CFR 1500.19(b)(1) and 16 CFR 1500.19(b)(2).

(f) Alternatives to cautionary state-ments for individual product advertise-ments in catalogues and other printed ma-terials. Multiple identical full or abbre-viated cautionary statements may be replaced with a single full cautionary statement under the following cir-cumstances:

(1) If all products available for pur-chase within a catalogue require the same cautionary statement, that cau-tionary statement, in full, may appear on the front cover, or equally con-spicuous location, of the catalogue in lieu of repeating the cautionary state-ment within the catalogue, provided that it is communicated to consumers that the cautionary statement applies to all products in the catalogue.

(2) If all products on one catalogue page or on two facing catalogue pages require the same cautionary state-ment, that cautionary statement, in full, may appear at the top of the page or pages in lieu of repeating the cau-tionary statement in each product ad-vertisement, provided that it is com-municated to consumers that the cau-tionary statement applies to all prod-ucts on the catalogue page or pages.

(g) Prominence and conspicuousness of labeling statements. The type size of ab-breviated cautionary statements shall be reasonably related to the type size of any other printed matter in the product advertisement, and must be in conspicuous and legible type by typog-raphy, layout, or color with other

printed matter in the advertisement and separated from other graphic mat-ter.

(h) Business to Business Catalogue Ex-ception. The requirements of section 24(c)of the Federal Hazardous Sub-stances Act, as amended by section 105 of the CPSIA, do not apply to cata-logues and other printed materials dis-tributed solely between businesses un-less the recipient business is one that could be expected to be purchasing the product for the use of children (instead of for resale, e.g.). Examples of busi-nesses that can be expected to be pur-chasing products for the use of children include day care centers, schools, and churches.

[73 FR 67736, Nov. 17, 2008, as amended at 73 FR 71545, Nov. 25, 2008]

§ 1500.40 Method of testing toxic sub-stances.

The method of testing the toxic sub-stances referred to in § 1500.3(c) (1)(ii)(C) and (2)(iii) is as follows:

(a) Acute dermal toxicity (single expo-sure). In the acute exposures, the agent is held in contact with the skin by means of a sleeve for periods varying up to 24 hours. The sleeve, made of rub-ber dam or other impervious material, is so constructed that the ends are re-inforced with additional strips and should fit snugly around the trunk of the animal. The ends of the sleeve are tucked, permitting the central portion to ‘‘balloon’’ and furnish a reservoir for


17N

O08

.100

</G

PH

>

459


the dose. The reservoir must have suffi-cient capacity to contain the dose without pressure. In the following table are given the dimensions of sleeves and the approximate body sur-face exposed to the test substance. The sleeves may vary in size to accommo-date smaller or larger subjects. In the testing of unctuous materials that ad-here readily to the skin, mesh wire screen may be employed instead of the sleeve. The screen is padded and raised

approximately 2 centimeters from the exposed skin. In the case of dry powder preparations, the skin and substance are moistened with physiological sa-line prior to exposure. The sleeve or screen is then slipped over the gauze that holds the dose applied to the skin. In the case of finely divided powders, the measured dose is evenly distributed on cotton gauze which is then secured to the area of exposure.

DIMENSIONS OF SLEEVES FOR ACUTE DERMAL TOXICITY TEST [Test animal—Rabbits]

Measurements in centimeters Range of weight of ani-mals (grams)

Average area of exposure (square centimeters)

Average percentage of total body surface Diameter at ends Overall length

7.0 12.5 2,500–3,500 240 10.7

(b) Preparation of test animal. The ani-mals are prepared by clipping the skin of the trunk free of hair. Approxi-mately one-half of the animals are fur-ther prepared by making epidermal abrasions every 2 or 3 centimeters lon-gitudinally over the area of exposure. The abrasions are sufficiently deep to penetrate the stratum corneum (horny layer of the epidermis) but not to distrub the derma; that is, not to ob-tain bleeding.

(c) Procedures for testing. The sleeve is slipped onto the animal which is then placed in a comfortable but immo-bilized position in a multiple animal holder. Selected doses of liquids and so-lutions are introduced under the sleeve. If there is slight leakage from the sleeve, which may occur during the first few hours of exposure, it is col-lected and reapplied. Dosage levels are adjusted in subsequent exposures (if necessary) to enable a calculation of a dose that would be fatal to 50 percent of the animals. This can be determined from mortality ratios obtained at var-ious doses employed. At the end of 24 hours the sleeves or screens are re-moved, the volume of unabsorbed ma-terial (if any) is measured, and the skin reactions are noted. The subjects are cleaned by thorough wiping, observed for gross symptoms of poisoning, and then observed for 2 weeks.

§ 1500.41 Method of testing primary ir-ritant substances.

Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the al-bino rabbit, clipped free of hair. A min-imum of six subjects are used in ab-raded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an ap-propriate solvent and apply the solu-tion as for liquids. The animals are im-mobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an im-pervious material, such as rubberized cloth, for the 24-hour period of expo-sure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reac-tions are evaluated on the basis of the designated values in the following table:

Skin reaction Value 1

Erythema and eschar formation: No erythema ................................................... 0 Very slight erythema (barely perceptible) ...... 1 Well-defined erythema ................................... 2 Moderate to severe erythema ........................ 3 Severe erythema (beet redness) to slight

eschar formations (injuries in depth) .......... 4


460

16 CFR Ch. II (1–1–10 Edition) § 1500.42

Skin reaction Value 1

Edema formation: No edema ....................................................... 0 Very slight edema (barely perceptible) .......... 1 Slight edema (edges of area well defined by

definite raising) ........................................... 2 Moderate edema (raised approximately 1

millimeter) ................................................... 3 Severe edema (raised more than 1 millimeter

and extending beyond the area of expo-sure) ............................................................ 4

1 The ‘‘value’’ recorded for each reading is the average value of the six or more animals subject to the test.

Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of ex-posures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not suffi-ciently deep to disturb the derma or to produce bleeding. Evaluate the reac-tions of the abraded skin at 24 hours and 72 hours, as described in this para-graph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score; for exam-ple:

Skin reaction Exposure

time (hours)

Evalua-tion value

Erythema and eschar formation: Intact skin ................................... 24 2

Do ........................................... 72 1 Abraded skin .............................. 24 3

Do ........................................... 72 2

Subtotal ............................ ................ 8

Edema formation: Intact skin ................................... 24 0

Do ........................................... 72 1 Abraded skin .............................. 24 1

Do ........................................... 72 2

Subtotal ............................ ................ 4

Total ................................. ................ 12

Thus, the primary irritation score is 12÷4=3.

§ 1500.42 Test for eye irritants. (a)(1) Six albino rabbits are used for

each test substance. Animal facilities for such procedures shall be so designed

and maintained as to exclude sawdust, wood chips, or other extraneous mate-rials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye de-fects or irritation shall be used. The animal is held firmly but gently until quiet. The test material is placed in one eye of each animal by gently pull-ing the lower lid away from the eyeball to form a cup into which the test sub-stance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a con-trol. For testing liquids, 0.1 milliliter is used. For solids or pastes, 100 milli-grams of the test substance is used, ex-cept that for substances in flake, gran-ule, powder, or other particulate form the amount that has a volume of 0.1 milliliter (after compacting as much as possible without crushing or altering the individual particles, such as by tap-ping the measuring container) shall be used whenever this volume weighs less than 100 milligrams. In such a case, the weight of the 0.1 milliliter test dose should be recorded. The eyes are not washed following instillation of test material except as noted below.

(2) The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours. Reading of reac-tions is facilitated by use of a bin-ocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after ap-plying fluorescein. For this optional test, one drop of fluorescein sodium ophthalmic solution U.S.P. or equiva-lent is dropped directly on the cornea. After flushing out the excess fluores-cein with sodium chloride solution U.S.P. or equivalent, injured areas of the cornea appear yellow; this is best visualized in a darkened room under ul-traviolet illumination. Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent after the 24-hour reading.

(b)(1) An animal shall be considered as exhibiting a positive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stippling), or opacity of the cornea (other than a slight


461


1 The Illustrated Guide is out of print and, as of January 1, 1981, no longer available. However, information about the test method, and black and white photocopies may be ob-tained by writing to the Directorate for Epi-demiology and Health Sciences, CPSC, Wash-ington, D.C. 20207, (301) 504–0957.

dulling of the normal luster), or in-flammation of the iris (other than a slight deepening of the folds (or rugae) or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctivae (exclud-ing the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse crimson-red with indi-vidual vessels not easily discernible.

(2) The test shall be considered posi-tive if four or more of the animals in the test group exhibit a positive reac-tion. If only one animal exhibits a posi-tive reaction, the test shall be regarded as negative. If two or three animals a positive reaction, the test is repeated using a different group of six animals. The second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test ex-hibit a positive reaction, the test shall be repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits a positive response.

(c) To assist testing laboratories and other interested persons in inter-preting the results obtained when a substance is tested in accordance with the method described in paragraph (a) of this section, an ‘‘Illustrated Guide for Grading Eye Irritation by Haz-ardous Substances’’ will be sold by the Superintendent of Documents, U.S. Government Printing Office, Wash-ington, D.C. 20402. 1 The guide will con-tain color plates depicting responses of varying intensity to specific test solu-tions. The grade of response and the substance used to produce the response will be indicated.

[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973; 62 FR 46667, Sept. 4, 1997]

§ 1500.43 Method of test for flashpoint of volatile flammable materials by Tagliabue open-cup apparatus.

SCOPE

1. (a) This method describes a test proce-dure for the determination of open-cup flashpoints of volatile flammable materials having flashpoints below 175 °F.

(b) This method, when applied to paints and resin solutions which tend to skin over or which are very viscous, gives less repro-ducible results than when applied to sol-vents.

OUTLINE OF METHOD

2. The sample is placed in the cup of a Tag Open Tester, and heated at a slow but con-stant rate. A small test flame is passed at a uniform rate across the cup at specified in-tervals. The flashpoint is taken as the lowest temperature at which application of the test flame causes the vapor at the surface of the liquid to flash, that is, ignite but not con-tinue to burn.

APPARATUS

3. The Tag open-cup tester is illustrated in Fig. 1. It consists of the following parts, which must conform to the dimensions shown, and have the additional characteris-tics as noted:

(a) Copper bath, preferably equipped with a constant level overflow so placed as to main-tain the bath liquid level 1⁄8-inch below the rim of the glass cup.

VerDate Nov<24>2008 15:16 Feb 23, 2010 Jkt 220052 PO 00000 Frm 00471 Fmt 8010 Sfmt 8010 Q:\16\16V2 ofr150 PsN: PC150 EC

03O

C91

.051

</G

PH

>

462

16 CFR Ch. II (1–1–10 Edition) § 1500.43

(b) Thermometer holder. Support firmly with ringstand and clamp.

(c) Thermometer. For flashpoints above 40 °F., use the ASTM Tag Closed Tester Ther-mometer, range of +20 to +230 °F., in 1 °F. di-visions, and conforming to thermometer 9F. of ASTM Standard E 1. For flashpoints from 20 °F. to 40 °F., use ASTM Tag Closed Tester, Low Range, Thermometer 57F. For flashpoints below 20 °F., use ASTM Ther-mometer 33F. The original Tag Open-Cup (Paper Scale) Thermometer will be a permis-sible alternate until January 1, 1962. It is calibrated to ¥20 °F.

(d) Glass test cup. Glass test cup (Fig. 2), of molded clear glass, annealed, heat-resistant, and free from surface defects.

(e) Leveling device. Leveling device or guide, for proper adjustment of the liquid level in the cup (Fig. 3). This shall be made of No. 18-gage polished aluminum, with a projection for adjusting the liquid level when the sample is added to exactly 1⁄8-inch below the level of the edge or rim of the cup.

(f) ‘‘Micro,’’ or small gas burner of suitable dimensions for heating the bath. A screw clamp may be used to help regulate the gas. A small electric heater may be used.

(g) Ignition taper, which is a small straight, blow-pipe type gas burner. The test

flame torch prescribed in the method of test for flash and fire points by Cleveland Open Cup (ASTM designation: D 92) is satisfac-tory.

(h) Alternative methods for maintaining the ignition taper in a fixed horizontal plane above the liquid may be used, as follows:

(1) Guide wire, 3⁄32-inch in diameter and 31⁄2 inches in length, with a right-angle bend 1⁄2- inch from each end. This wire is placed snug-ly in holes drilled in the rim of the bath, so that the guide wire is 5⁄8-inch from the center of the cup and resting on the rim of the cup.

(2) Swivel-type taper holder, such as is used in ASTM METHOD D 92. The height and position of the taper are fixed by adjusting the holder on a suitable ringstand support adjacent to the flash cup.

(i) Draft shield, consisting of two rectan-gular sheets of noncombustible material, 24 inches × 28 inches, are fastened together along the 28-inch side, preferably by hinges. A triangular sheet, 24 inches × 24 inches × 34 inches is fastened by hinges to one of the lat-eral sheets (to form a top when shield is open). The interior of the draft shield shall be painted a flat black.

PROCEDURE

4. (a) Place the tester on a solid table free of vibration, in a location free of perceptible draft, and in a dim light.

(b) Run water, brine, or water-glycol solu-tion into the bath to a predetermined level, which will fill the bath to 1⁄8-inch below the top when the cup is in place. An overflow is permissible for water-level control.

(c) Firmly support the thermometer vertically halfway between the center and edge of the cup on a diameter at right angles to the guide wire, or on a diameter passing through the center of the cup and the pivot of the taper. Place so that the bottom of the bulb is 1⁄4-inch from the inner bottom surface of the cup. If the old Tagliabue thermometer is used, immerse to well cover the mercury bulb, but not the wide body of the thermom-eter.

(d) Fill the glass cup with the sample liq-uid to a depth just 1⁄8-inch below the edge, as determined by the leveling device.

(e) Place the guide wire or swivel device in position, and set the draft shield around the tester so that the sides from right angles with each other and the tester is well toward the back of the shield.

(f) If a guide wire is used, the taper, when passed, should rest lightly on the wire, with the end of the jet burner just clear of the edge of the guide wire. If the swivel-type holder is used, the horizontal and vertical positions to the jet are so adjusted that the jet passes on the circumference of a circle, having a radius of at least 6 inches, across the center of the cup at right angles to the diameter passing through the thermometer, and in a plane 1⁄8-inch above the upper edge


03O

C91

.052

</G

PH

>E

C03

OC

91.0

53<

/GP

H>

463


of the cup. The taper should be kept in the ‘‘off’’ position, at one end or the other of the swing, except when the flame is applied.

(g) Light the ignition flame and adjust it to form a flame of spherical form matching in size the 5⁄52-inch sphere on the apparatus.

(h) Adjust heater source under bath so that the temperature of the sample increases at a rate of 2±0.5 °F. per minute. With viscous ma-terials this rate of heating cannot always be obtained.

INITIAL TEST

5. Determine an approximate flashpoint by passing the taper flame across the sample at intervals of 2 °F. Each pass must be in one direction only. The time required to pass the ignition flame across the surface of the sam-ple should be 1 second. Remove bubbles from the surface of the sample liquid before start-ing a determination. Meticulous attention to all details relating to the taper, size of taper flame, and rate of passing the taper is nec-essary for good results. When determining the flashpoint of viscous liquids and those liquids that tend to form a film of polymer, etc., on the surface, the surface film should be disturbed mechanically each time before the taper flame is passed.

RECORDED TESTS

6. Repeat the procedure by cooling a fresh portion of the sample, the glass cup, the bath solution, and the thermometer at least 20 °F. below the approximate flashpoint. Resume heating, and pass the taper flame across the sample at two intervals of 2 °F. until the flashpoint occurs.

REPORTING DATA

7. The average of not less than three re-corded tests, other than the initial test, shall be used in determining the flashpoint and flammability of the substance.

STANDARDIZATION

8. (a) Make determinations in triplicate on the flashpoint of standard paraxylene and of standard isopropyl alcohol which meet the following specifications:

(i) Specifications for p-xylene, flashpoint check grade. p-xylene shall conform to the fol-lowing requirements;

Specific gravity: 15.56 °C./15.56 °C., 0.860 min-imum, 0.866 maximum

Boiling range: 2 °C. maximum from start to dry point when tested in accordance with the method of test for distillation of indus-trial aromatic hydrocarbons (ASTM des-ignation: D 850), or the method of test for distillation range of lacquer solvents and diluents (ASTM) designation D 1078). The range shall include the boilng point of pure P-xylene, which is 138.35 °C. (281.03 °F.).

Purity: 95 percent minimum, calculated in accordance with the method of test for de-termination of purity from freezing points of high-purity compounds (ASTM designa-tion: D 1016), from the experimentally de-termined freezing point, measured by the method of test for measurement of freezing points of high-purity compounds for eval-uation of purity (ASTM designation: D 1015).

(ii) Specifications for ispropanol, flash point check grade. Isopropanol shall conform to the following requirements:

Specific gravity: 0.8175 to 0.8185 at 20 °C./20 °C. as determined by means of a calibrated pycnometer.

Distillation range: Shall entirely distill within a 1.0 °C. range which shall include the temperature 80.4 °C. as determined by ASTM method D 1078.

Average these values for each compound. If the difference between the values for these two compounds is less than 15 °F. (8.5 °C.) or more than 27 °F. (16 °C.), repeat the deter-minations or obtain fresh standards.

(b) Calculate a correction factor as follows:

X = 92 ¥ A Y = 71 ¥ B

Correction = (X + Y) / 2.

Where:

A=Observed flash of p- xylene, and B=Observed flash of isopropyl alcohol.

Apply this correction of all determinations. Half units in correction shall be discarded.

PRECISION

9. (a) For hydrocarbon solvents having flashpoints between 60 °F. and 110 °F., repeat-ability is ±2 °F. and the reproducibility is ±5 °F.

(b) If results from two tests differ by more than 10 °F., they shall be considered uncer-tain and should be checked. This calibration procedure provided in this method will can-cel out the effect of barometric pressure if calibration and tests are run at the same pressure. Data supporting the precision are given appendix III of the 1956 Report of Com-mittee D–1 on Paint, Varnish, Lacquers and Related Products, Proceedings, Am. Soc. Testing Mats., Vol. 56 (1956).

NOTE: The test apparatus and procedure de-scribed in § 1500.43 may be used by manufac-turers and labelers of products subject to the Federal Hazardous Substances Act to deter-mine flashpoint temperatures of those prod-ucts under the conditions set forth in § 1500.3(c)(6)(iv), as amended.

[51 FR 28537, Aug. 8, 1986]


464

16 CFR Ch. II (1–1–10 Edition) § 1500.43a

1 Setaflash is a registered trademark of Stanhope-Seta Limited, Surrey, England.

§ 1500.43a Method of test for flashpoint of volatile flammable materials.

(a) Scope. (1) This method describes the test procedure which the Commis-sion will use for the determination of the flashpoint of volatile flammable materials, using a Setaflash 1 low-range closed tester, or an apparatus pro-ducing equivalent results. The method described in this section is essentially a Setaflash equilibrium procedure which closely parallels the test method designated ASTM D 3828-81, ‘‘Standard Test Methods for Flash Point by Setaflash Closed Tester,’’ published by the American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, Pennsylvania 19103. Man-ufacturers and labelers of products sub-ject to labeling and other requirements under the Federal Hazardous Sub-stances Act may use other apparatus and/or test methods which produce equivalent results.

(2) At the option of the user, the pro-cedures described in this section may be used to determine the actual flashpoint temperature of a sample or to determine whether a product will or will not flash at a specified tempera-ture (flash/no flash).

(3) If the substance to be tested has a viscosity greater than 150 Stokes at 77 °F (25 °C), see paragraph (n) of this sec-tion for modifications to the testing procedure.

(4) If the Commission has reason to believe on the basis of reliable experi-ence or other relevant information or data that the flammability hazard of a substance is greater or less than its flammability classification based on flashpoint temperature determined in accordance with this § 1500.43a and that the substance should be reclassified, the Commission will initiate a rule-making proceeding for reclassification of the substance. Product manufactur-ers and labelers may use reliable expe-rience or other relevant information or data in addition to the flashpoint tem-perature of a substance as a basis for compliance with any applicable re-quirements of the Federal Hazardous Substances Act in the absence of a rule

issued by the Commission to reclassify the substance.

(b) Summary of test methods. (1) Meth-od A—Flash/No Flash Test. A specified volume of sample is introduced by a sy-ringe into the cup of the apparatus that is set and maintained at the speci-fied temperature. After a specific time a test flame is applied and an observa-tion made as to whether or not a flash occurred. Test procedures are set forth in detail in § 1500.43a(i).

(2) Method B—Finite (or Actual) Flashpoint. (i) A specified voume of sample is introduced into the cup of the apparatus that is maintained at the expected flashpoint. After a speci-fied time a test flame is applied and the observation made whether or not a flash occurred.

(ii) The specimen is removed from the cup, the cup cleaned, and the cup temperature adjusted 5 °C (9 °F), lower or higher depending on whether or not a flash occurred previously. A fresh specimen is introduced and tested. This procedure is repeated until the flashpoint is established within 5 °C (9 °F).

(iii) The procedure is then repeated at 1 °C (2 °F) intervals until the flashpoint is determined to the nearest 1 °C (2 °F).

(iv) If improved accuracy is desired the procedure is repeated at 0.5 °C (1 °F). Test procedures are set forth in de-tail at § 1500.43a(j).

(3) The test procedures will be modi-fied, where necessary, to ensure that the results obtained reflect the hazard of the substance under reasonably fore-seeable conditions of use. Thus, for ex-ample, the material, if a mixture, will normally be tested as it comes from the container, and/or after a period of evaporation. The period of evaporation for a material which is a mixture will normally be the time required for the mixture to evaporate in an open beaker under ambient conditions to 90 percent of its original volume, or a period of four hours, whichever occurs first. However, this period of evaporation will be changed if the results obtained do not represent the hazard of the sub-stance under reasonably foreseeable conditions of use.

(c) Definition of flashpoint. The lowest temperature of the sample, corrected


465

Consumer Product Safety Commission § 1500.43a

2 If the instrument has two temperature control knobs, set the fine control (center, small knob) at its mid-position and allow it to remain there throughout the calibration. The calibration is determined by adjusting the coarse control (large, outer knob) only.

3 When using the tester, it will be found that the indicator light may not illuminate and the temperature may not rise until a temperature control dial setting between one and two is reached.

to a barometric pressure of 101.3 kPa (760 mm Hg), at which application of a test flame causes the vapor of the sam-ple to ignite under specified conditions of test. The sample is deemed to have flashed when a large flame appears and instantaneously propagates itself over the surface of the sample. Occasion-ally, particularly near actual flashpoint, the application of the test flame will cause a halo or an enlarged flame; this is not a flash and should be ignored.

(d) Test apparatus. The test apparatus is an equilibrium closed-cup tester with a range up to 100 °C (212 °F). The essential dimensions and requirements are shown in figure 1 and table 3, and are described in § 1500.43a(m). Closed- cup flashpoint testers and accessories meeting these requirements are avail-able from commercial suppliers and distributors of laboratory equipment.

(e) Safety precautions. The operator must exercise and take appropriate safety precautions during the initial application of the test flame to the sample. Samples containing low-flash material may give an abnormally strong flash when the test flame is first applied.

(f) Preparation of samples. (1) Erro-neously high flashpoints may be ob-tained if precautions are not taken to avoid the loss of volatile material. In preliminary tests of materials taken directly from the container, do not open containers unnecessarily and make a transfer unless the sample tem-perature is at least 10 °C (18 °F) below the expected flashpoint. Do not use samples in leaky containers for this test.

(2) Do not store samples in plastic (polyethylene, polypropylene, etc.) bot-tles since volatile material may diffuse through the walls of the bottle.

(3) A 2-ml specimen is required for each test. If possible, obtain at least a 50-ml sample from the bulk test site and store in a clean, tightly closed con-tainer.

(g) Preparation of apparatus. (1) Place the tester on a level, stable surface. Unless tests are made in a draft-free area, surround the tester on three sides with a shield for protection. Do not rely on tests made in a laboratory draft hood or near ventilators.

(2) Read the manufacturer’s instruc-tions on the care and servicing of the instrument and for correct operation of its controls.

(h) Calibration and standardization. (1) Before initial use determine and plot the relationship between the tempera-ture control dial and the thermometer readings at each major (numbered) dial division as follows:

Turn the temperature control knob 2 fully counterclockwise (‘‘O’’ reading). Advance the temperature control knob clockwise until the indicator light is illuminated. 3 Advance the knob clock-wise to the next numbered line. After the thermometer mercury column ceases to advance, record the dial read-ing and the temperature. Advance the knob clockwise to the next numbered line. After the thermometer mercury column ceases to advance, read the dial reading and the temperature. Repeat this procedure through the full range of the instrument. Plot the dial read-ings versus the respective tempera-tures.

(2) Standardize the instrument using a sample of material meeting the speci-fications in table 1. If the average of two determinations falls within the ac-ceptable limits the instrument is as-sumed to be operating properly. If the average of the two determinations does not fall within this range, check the manufacturer’s operating and mainte-nance instructions and determine that they are being followed. In particular, be sure that the cup lid assembly makes a vapor-tight seal with the cup, the shutter provides a light-tight seal, and that adequate heat transfer paste surrounds the thermometer bulb and the immersed portion of the barrel.

(i) Test Method A—for determining Flash/No Flash. (1) Determine the tar-get flashpoint as follows:


466


4 The barometric pressure used in this cal-culation must be the ambient pressure for the laboratory at the time of test. Many an-eroid barometers, such as those used at weather stations and airports, are precorrected to give sea-level readings; these must not be used.

5 If the target or specification temperature is not less than 5 °C (40 °F) crushed ice and water may be used as charging (cooling) fluid. If below 5 °C (40 °F), a suitable charg-ing (cooling) fluid is solid carbon dioxide (dry ice) and acetone. If the refrigerant charged cooling module is unavailable, refer to the manufacturer’s instruction manual for alternative methods of cooling.

6 The target temperature may be attained by originally turning the coarse temperature control knob to the proper setting (see § 1500.43a(h)(1) for the temperature desired rather than the maximum setting (full on). The elapsed time to reach the temperature will be greater, except for maximum tem-perature. However, less attention will be re-quired during the intervening period.

7 For target or expected temperatures below ambient, both syringe and sample must be precooled to cup temperature (see § 1500.43a(i)(3)(i)) before the specimen is taken.

8 For target temperatures below ambient, do not set the timer. Adjust the test flame

(i) Target flashpoint, °C=Sc—0.25 (101.3—A)

(ii) Target flashpoint, °C=Sc—0.03 (760–B)

(iii) Target flashpoint, °F=Sf—0.06 (760–B)

where:

Sc=specification, or uncorrected target, flashpoint, °C,

Sf=specification, or uncorrected target, flashpoint, °F,

B=ambient barometric pressure, mm Hg, 4 and

A=ambient barometer pressure, kPa. 4

(2) Inspect the inside of the sample cup, lid, and shutter mechanism for cleaniness and freedom from contami-nation. Use an absorbent paper tissue to wipe clean, if necessary. Put cover in place and lock securely. The filing orifice may be convenienty cleaned with a pipe cleaner.

(3) Set the instrument at the target temperature.

(i) For target temperature below am-bient. The instrument power switch is to be in the off position. Fill the refigerant-charged cooling block with a suitable material. 5 Raise the lid and shutter assembly, and position the base of the block in the sample cup, being careful not to injure or mar the cup. When the thermometer reads approxi-mately 6 to 10 °C (10 to 20 °F) below the target temperature, remove the cooling block and quickly dry the cup with a paper tissue to remove any moisture. Immediately close the lid and shutter assembly and secure. Prepare to intro-duce the sample using the syringe, both of which have been precooled to a temperature 5 to 10 °C (10 to 20 °F) below the target temperature.

(A) Caution: Do not cool the sample block below ¥38 °C, the freezing point of mercury.

(B) Caution: Acetone is extremely flammable. Keep away from heat, sparks, and flames and keep container closed when not actually pouring ace-tone. Use only in a well-ventilated area. Avoid inhalation and contact with the eyes or skin. Use cloth or leather gloves, goggles or safety shield, and keep dry ice in a canvas bag, espe-cially when cracking.

(ii) For target temperature above ambient. Switch the instrument on and turn the coarse temperature control knob fully clockwise (full on) causing the indicator light to illuminate. 6 When the thermometer indicates a temperature about 3 °C (5 °F) below the target (or specification) temperature, reduce the heat input to the sample cup by turning the coarse temperature control knob counter-clockwise to the desired control point (see § 1500.43a(i)(1)). When the indicator light slowly cycles on and off read the temperature on the thermometer. If necessary, adjust the fine (center) tem-perature control knob to obtain the de-sired test (target) temperature. When the test temperature is reached and the indicator lamp slowly cycles on and off, prepare to introduce the sample.

(4) Charge the syringe with a 2-ml specimen of the sample 7 to be tested; transfer the syringe to the filling ori-fice, taking care not to lose any sam-ple; discharge the test specimen into the cup by fully depressing the syringe plunger, remove the syringe.

(5)(i) Set the timer 8 by rotating its knob clockwise to its stop. Open the


467


and allow the temperature to rise under am-bient conditions until the target tempera-ture is reached. Immediately apply the test flame as detailed.

9 Never apply the test flame to the speci-men more than once. Fresh portions of the sample must be used for each test.

10 For expected flashpoint below ambient, do not set the timing device. Adjust the test flame. Allow the temperature to rise under ambient conditions until the temperature reaches 5 °C (9 °F) below the expected flashpoint. Immediately apply the test flame.

gas control valve and light the pilot and test flames. Adjust the test flame with the pinch valve to conform to the size of the 4-mm (5/32-in.) gage.

(ii) After the time signal indicates the specimen is at test temperature 8, apply the test flame by slowly and uni-formly opening the shutter and closing it completely over a period of approxi-mately 21⁄2 s. 9 Watch closely for a flash at the cup openings.

(iii) The sample is deemed to have flashed when a large flame appears and instantaneously propagates itself over the surface of the sample (see § 1500.43a(c)).

(6) Record the test results as ‘‘flash’’ or ‘‘no flash’’ and the test temperature.

(7) Turn off the pilot and test flames using the gas control valve. Remove the sample and clean the instrument. It may be necessary to allow the cup temperature to decline to a safe level before cleaning.

(j) Test Method B—for determining Fi-nite or Actual Flashpoint. (1) Inspect the inside of the sample cup, lid, and shut-ter mechanism for cleanliness and free-dom from contamination. Use an ab-sorbent paper tissue to wipe clean, if necessary. Put cover in place and lock securely. The filling orifice may be conveniently cleaned with a pipe clean-er.

(2) For expected flashpoints below ambient. (i) The instrument power switch is to be in off position. Fill the refrigerant-charged cooling block with a suitable material. 5 Raise the lid and shutter assembly, and position the base of the block in the sample cup, being careful not to injure or mar the cup. When the thermometer reaches a tem-perature 5 to 10 °C (10 to 20 °F) below the expected flashpoint, remove the cooling block and quickly dry the cup with a paper tissue to remove any moisture. Immediately close the lid and shutter assembly and secure. Pre-pare to introduce the sample using the syringe, both of which have been precooled to a temperature 5 to 10 °C

(10 to 20 °F) below the expected tem-perature (See § 1500.43a(j)(5)).

(ii) Caution: Do not cool the sample block below ¥38 °C, the freezing point of mercury.

(3) For tests where the expected flashpoint is above ambient. Turn the coarse temperature control knob fully clockwise (full on) causing the indi-cator light to illuminate. When the thermometer reaches a temperature 3 °C (5 °F) below the estimated flashpoint, turn the coarse tempera-ture knob counter-clockwise to the dial reading representing the estimated flashpoint temperature as shown on the calibration curve (See § 1500.43a(h)(1)). When the indicator light slowly cycles on and off, read the temperature on the thermometer. If necessary, adjust the fine temperature control knob to obtain the exact de-sired temperature.

(4)(i) Charge the syringe 7 with a 2 ml specimen of the sample 7 to be tested; transfer the syringe to the filling ori-fice, taking care not to lose any sam-ple; discharge the test specimen into the cup by fully depressing the syringe plunger; remove the syringe.

(ii) Set the timer 10 by rotating its knob clockwise to its stop. Open the gas control valve and ignite the pilot and test flames. Adjust the test flame with the pinch valve to conform to the size of the 4-mm (5⁄32-in.) gage.

(iii) After the audible time signal in-dicates the specimen is at test tem-perature, 10 apply the test flame by slowly and uniformly opening the shut-ter and then closing it completely over a period of approximately 21⁄2 s. Watch closely for a flash at the cup opening.

(iv) The sample is deemed to have flashed only if a large flame appears and instantaneously propagates itself over the surface of the sample. (See § 1500.43a(c).)

(v) Turn off the pilot and test flames using the gas control valve. When the cup temperature declines to a safe


468


level, remove the sample and clean the instrument.

(5)(i) If a flash was observed in § 1500.43a(j)(4)(iii) repeat the procedure given in § 1500.43a(j)(2) or (3), and in § 1500.43a(j)(4), testing a new specimen at a temperature 5 °C (9 °F) below that at which the flash was observed.

(ii) If necessary, repeat the procedure in § 1500.43a(j)(5)(i), lowering the tem-perature 5 °C (9 °F) each time, until no flash is observed. 9

(iii) Proceed to § 1500.43a(j)(7). (6)(i) If no flash was observed in

§ 1500.43a(j)(4)(iii) repeat the procedure given in § 1500.43a(j)(2) or (3), and in § 1500.43a(j)(4), testing a fresh specimen at a temperature 5 °C (9 °F) above that at which the specimen was tested in § 1500.43a(j)(4)(iii).

(ii) If necessary repeat the procedure in § 1500.43a(j)(6)(i), above, raising the temperature 5 °C (9 °F) each time until a flash is observed. 9

(7) Having established a flash within two temperatures 5 °C (9 °F) apart, re-peat the procedure at 1 °C (2 °F) inter-vals from the lower of the two tem-peratures until a flash is observed. 9 Record the temperature of the test when this flash occurs as the flashpoint, allowing for any known thermometer correction. Record the barometric pressure. 4

(8) The flashpoint determined in § 1500.43a(j)(7) will be to the nearest 1 °C (2 °F). If improved accuracy is desired (that is, to the nearest 0.5 °C (1 °F)), test a fresh specimen at a temperature 0.5 °C (1 °F) below that at which the flash was observed in § 1500.43a(j)(7). If no flash is observed, the temperature recorded in § 1500.43a(j)(7), is the flashpoint to the nearest 0.5 °C (1 °F). If a flash is observed at the lower tem-perature, record this latter tempera-ture as the flashpoint.

(9) Turn off the pilot and test flames using the gas control valve. When the cup temperature declines to a safe level, remove the sample and clean the instrument.

(k) Calculations. If it is desired to cor-rect the observed finite flashpoint for the effect of barometric pressure, pro-ceed as follows: Observe and record the ambient barometric pressure 4 at the time of the test. If the pressure differs

from 101.3 kPa (760 mm Hg), correct the flashpoint as follows:

(1) Corrected flashpoint ( °C)=C+0.25 (101.3–A)

(2) Corrected flashpoint ( °F)=F+0.06 (760–B)

(3) Corrected flashpoint ( °C)=C+0.03 (760–B) Where: F=Observed flashpoint, °F, C=observed flashpoint, °C, B=ambient barometric pressure, mm Hg; and A=ambient barometric pressure, kPa.

(l) Precision. The precision of the method as determined by statistical examination of interlaboratory results is as follows:

(1) Repeatability. The difference be-tween two test results obtained by the same operator with the same apparatus under constant operating conditions on identical test material, would, in the long run, in the normal and correct op-eration of the test method, exceed the values shown in table 2 only in 1 case in 20.

(2) Reproducibility. The difference between two single and independent re-sults obtained by different operators working in different laboratories on identical test material, would, in the long run, in the normal and correct op-eration of the test method, exceed the values shown in table 2 only in 1 case in 20.

(m) Flash Test Apparatus. (1)(i) Unit consisting of an aluminum alloy or nonrusting metal block of suitable con-ductivity with a cylindrical depression, or sample cup, over which is fitted a cover. A thermometer is embedded in the block.

(ii) The cover is fitted with an open-ing slide and a device capable of insert-ing an ignition flame (diameter 4±0.5 mm) into the well when the slide de-vice shall intersect the plane of the un-derside of the cover. The cover is also provided with an orifice extending into the sample well for insertion of the test sample and also a suitable clamp-ing device for securing the cover tight-ly to the metal block. The three open-ings in the cover shall be within the di-ameter of the sample well. When the slide is in the open position, the two openings in the slide shall coincide ex-actly with the two corresponding open-ings in the cover.

(iii) Electrical heaters are attached to the bottom of the cup in a manner


469


that provides efficient transfer of heat. An electronic heat control is required to hold the equilibrium temperature, in a draft-free area, within 0.1 °C (0.2 °F) for the low-temperature tester. A vis-ual indicator lamp shows when energy is or is not being applied. Energy may be supplied from 120 or 240 V, 50 or 60 Hz main service.

(2)(i) Test flame and pilot flame- regulatable test flame, for dipping into the sample cup to try for flash, and a pilot flame, to maintain the test flame, are required. These flames may be fueled by piped gas service. A gage ring 4mm (5/32 in.) in diameter, engraved on the lid near the test flame, is required to ensure uniformity in the size of the test flame.

(ii) Caution: Never recharge the self- contained gas tank at elevated tem-perature, or with the pilot or test flames lighted, nor in the vicinity of other flames.

(iii) Audible Signal is required. The audiable signal is given after 1 min in the case of the low-temperature tester.

(iv) Syringe. 2ml capacity, equipped with a needle suitable for use with the apparatus, adjusted to deliver 2.00±0.05 ml.

(3) Essential dimensions of the test apparatus are set forth in table 3.

(n) Testing high-viscosity liquids. (1) High-viscosity materials may be added to the cup by the following procedure:

(i) Back load a 5 or 10-ml syringe with the sample to be tested and ex-trude 2 ml into the cup. Spread the specimen as evenly as possible over the bottom of the cup.

(ii) If the sample cannot be loaded into a syringe and extruded, other means of adding the sample to the cup may be used such as a spoon. Add ap-proximately 2 ml of material to the spoon and then push the material from the spoon into the cup.

(iii) If the test specimen does not close the sampling port in the cup, seal the cup externally by suitable means.

(2) Using the appropriate procedure, either Method A in § 1500.43a(i) or Method B in § 1500.43a(j), determine the flashpoint of the specimen which has been added to the tester in accordance with § 1500.43a(n)(i), except that the time specified is increased from 1 to 5

minutes for samples at or above ambi-ent temperature.

TABLE 1—CALIBRATION OF TESTER Material .................................. p-xyleneA (Caution).B Specific gravity. 15.6/15.6 °C

(60/60 °F).0.850 to 0.866.

Boiling range .......................... 2 °C maximum including 138.35 °C (281.03 °F).

Freezing point ........................ 11.23 °C (52.2 °F) minimum. Flashpoint °C (acceptable

range).25.6±0.5 (78±1 F).

A Available as Flash Point Check Fluid (p-xylene) from Spe-cial Products Div., Phillips Petroleum Co., Drawer ‘O,’ Borger, Texas 79007.

B Caution: Handle xylene with care. Avoid inhalation; use only in a well-ventilated area. Avoid prolonged or repeated contact with skin. Keep away from flames and heat, except as necessary for the actual flash point determination.

TABLE 2—REPEATABILITY AND REPRODUCIBILITY

Temperature, °C ( °F) Repeatability, °C ( °F)

Reproducibility, °C ( °F)

20(68) ................................ 0.5(0.9) 1.4(2.6) 70(158) .............................. 0.5(0.9) 2.9(5.3) 93(200) .............................. 1.3(2.3) 4.9(8.8) 150(300) ............................ 2.0(3.6) 7.5(13.5) 200(400) ............................ 2.6(4.7) 9.9(17.9) 260(500) ............................ 3.3(5.9) 12.4(22.3)

TABLE 3—ESSENTIAL DIMENSIONS OF FLASH TEST APPARATUS A,B

Sample Block Block diameter ................................................. 61.5–62.5 Sample well diameter ...................................... 49.40–49.70 Sample well depth ........................................... 9.70–10.00 Top of block to center of thermometer hole .... 16.00–17.00 Diameter of thermometer hole (approx.) ......... 7.0004

Cover Large opening length ....................................... 12.42–12.47 Large opening width ........................................ 10.13–10.18 Small opening length ....................................... 5.05–5.10 Small opening width ........................................ 7.60–7.65 Distance between extreme edges of small

openings ....................................................... 48.37–48.32 Filling orifice diameter ...................................... 4.00–4.50 Bore or filler tube ............................................. 1.80–1.85 Maximum distance of filler tube from base of

well with cover closed (max.) ....................... 0.75 Slide

Large opening length ....................................... 12.42–12.47 Large opening width ........................................ 10.13–10.18 Small opening length ....................................... 5.05–5.10 Small opening width ........................................ 7.60–7.65 Near edge of large opening to end of slide .... 12.80–12.85 Extremes of large and small openings ............ 30.40–30.45

Jet Length of jet ..................................................... 18.30–18.40 External diameter at end of jet ........................ 2.20–2.60 Bore of jet ........................................................ 1.60–1.65 Height of jet center above top surface of

cover ............................................................. 11.00–11.20 Jet pivot to center of block with cover closed 12.68–12.72

A The O-seal or gasket which provides a seal when the cover is shut, should be made of a heat-resistant material ca-pable of withstanding temperatures up to 150 °C for the low- range apparatus.

B When in position, the thermometer bulb should be sur-rounded with heat-conducting thermoplastic compound, such as a paste comprised of zinc oxide and mineral oil.


470

16 CFR Ch. II (1–1–10 Edition) § 1500.44

[51 FR 28539, Aug. 8, 1986]

§ 1500.44 Method for determining ex-tremely flammable and flammable solids.

(a) Preparation of samples—(1) Gran-ules, powders, and pastes. Pack the sam-ple into a flat, rectangular metal boat with inner dimensions 6 inches long × 1 inch wide × one-fourth inch deep.

(2) Rigid and pliable solids. Measure the dimensions of the sample and sup-

port it by means of metal ringstands, clamps, rings, or other suitable devices as needed, so that the major axis is ori-ented horizontally and the maximum surface is freely exposed to the atmos-phere.

(b) Procedure. Place the prepared sample in a draft-free area that can be ventilated and cleared after each test. The temperature of the sample at the


03O

C91

.054

</G

PH

>

471


time of testing shall be between 68 °F. and 86 °F. Hold a burning paraffin can-dle whose diameter is at least 1 inch, so that the flame is in contact with the surface of the sample at the end of the major axis for 5 seconds or until the sample ignites, whichever is less. Re-move the candle. By means of a stop-watch, determine the time of combus-tion with self-sustained flame. Do not exceed 60 seconds. Extinguish flame with a CO2 or similar nondestructive type extinguisher. Measure the dimen-sions of the burnt area and calculate the rate of burning along the major axis of the sample.

§ 1500.45 Method for determining ex-tremely flammable and flammable contents of self-pressurized con-tainers.

(a) Equipment required. The test equipment consists of a base 8 inches wide, 2 feet long, marked in 6-inch in-tervals. A rule 2 feet long and marked in inches is supported horizontally on the side of the base and about 6 inches above it. A paraffin candle 1 inch or more in diameter, and of such height that the top third of the flame is at the height of the horizontal rule, is placed at the zero point in the base.

(b) Procedure. The test is conducted in a draft-free area that can be venti-lated and cleared after each test. Place the self-pressurized container at a dis-tance of 6 inches from the flame source. Spray for periods of 15 seconds to 20 seconds (one observer noting the extension of the flame and the other operating the container) through the top third of the flame and at a right angle to the flame. The height of the flame should be approximately 2 inches. Take three readings for each test, and average. As a precaution do not spray large quantities in a small, confined space. Free space of pre-viously discharged material.

§ 1500.46 Method for determining flashpoint of extremely flammable contents of self-pressurized con-tainers.

Use the apparatus described in § 1500.43a. Use some means such as dry ice in an open container to chill the pressurized container. Chill the con-tainer, the flash cup, and the bath solu-tion of the apparatus (brine or glycol

may be used) to a temperature of about 25 °F below zero. Puncture the chilled container to exhaust the propellant. Transfer the chilled formulation to the test apparatus and test in accordance with the method described in § 1500.43a.

[51 FR 28544, Aug. 8, 1986]

§ 1500.47 Method for determining the sound pressure level produced by toy caps.

(a) Equipment required. The equip-ment for the test includes a micro-phone, a preamplifier (if required), and an oscilloscope.

(1) The microphone-preamplifier sys-tem shall have a free-field response uniform to within ±2 decibels from 50 hertz to 70 kilohertz or beyond and a dynamic range covering the interval 70 to 160 decibels relative to 20 micronew-tons per square meters. Depending on the model, the microphone shall be used at normal or at grazing incidence, whichever gives the most uniform free- field response. The microphone shall be calibrated both before and after the test of a model of cap. The calibration shall be accurate to within ±1 decibel. If the calibration is of the pressure type or of the piston-phone plus elec-trostatic actuator type, it shall be cor-rected to free-field conditions in ac-cordance with the manufacturer’s in-structions.

(2) The oscilloscope shall be the stor-age type or one equipped with a cam-era. It shall have a response uniform to within ±1 decibel from 50 hertz to 250 kilohertz or higher. It shall be cali-brated to within ±1 decibel against an external voltage source periodically during the tests.

(b) Procedure. (1) Use the type pistol that would ordinarily be used with the caps being tested. Place the pistol and testing equipment so that neither the pistol nor the microphone is closer than 1 meter from any wall, floor, ceil-ing, or other large obstruction. Locate the pistol and the microphone in the same horizontal plane with a distance of 25 centimeters between the dia-phragm of the microphone and the po-sition of the explosive. Measure the peak sound pressure level at each of the six designated orientations of the pistol with respect to the measuring


472

16 CFR Ch. II (1–1–10 Edition) § 1500.48

microphone. The 0° orientation cor-responds to the muzzle of the pistol pointing at the microphone. The 90°, 180°, and 270° orientations are measured in a clockwise direction when looking down on the pistol with its barrel hori-zontal, as illustrated by the following figure:

(2) The hammer and trigger orienta-tions are obtained by rotating the pis-tol about the axis of the barrel, when the pistol is in the 90° or 270° orienta-tion, so that the hammer and the trig-ger are each respectively closest to and in the same horizontal plane with the microphone.

(3) Fire 10 shots at each of the six ori-entations, obtaining readings on the oscilloscope of the maximum peak voltage for each shot. Average the re-sults of the 10 firings for each of the six orientations.

(4) Using the orientation that yields the highest average value, convert the value to sound pressure levels in deci-bels relative to 20 micronewtons per square meter using the response to the calibrated measuring microphone.

§ 1500.48 Technical requirements for determining a sharp point in toys and other articles intended for use by children under 8 years of age.

(a) Objective. The sharp point test prescribed by paragraph (d) of this sec-tion will be used by the Commission in making a preliminary determination that points on toys and other articles intended for use by children under 8 years of age, and such points exposed in normal use or as a result of reason-ably foreseeable damage or abuse of such toys and articles, present a poten-tial risk of injury by puncture or lac-eration under section 2(s) of the Fed-eral Hazardous Substances Act (15

U.S.C. 1261(s)). The Commission will further evaluate points that are identi-fied as presenting a potential risk of puncture or laceration injury to deter-mine the need for individual product regulatory action.

(b) Scope—(1) General. The sharp point test of paragraph (d) of this sec-tion is applicable to toys or other arti-cles that are introduced into interstate commerce on or after December 22, 1978. The sharp point test shall be ap-plied to any accessible portion of the test sample before and after subjecting the test sample to the use and abuse tests of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test-paragraph (c) of each section).

(2) Exemptions. (i) Toys and other children’s articles that are the subject of any of the following regulations are exempt from this § 1500.48: The regula-tions for bicycles, non-full-size baby cribs, and full-size baby cribs (parts 1508, 1509, and 1512, of this chapter).

(ii) Toys that by reason of their func-tional purpose necessarily present the hazard of sharp points and that do not have any nonfunctional sharp points are exempt from this § 1500.48: Provided, Each toy is identified by a conspicuous, legible, and visible label at the time of any sale, as having functional sharp points. An example of such toys is a toy sewing machine with a needle.

(iii) Articles, besides toys, intended for use by children that by reason of their functional purpose necessarily present the hazard of sharp points and that do not have any nonfunctional sharp points are exempt from this § 1500.48. An example of such articles is a ball-point pen.

(c) Accessibility—(1) General. Any point that is accessible either before or after these tests of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test— paragraph (c) of each section) are per-formed shall be subject to the sharp point test of paragraph (d) of this sec-tion.

(2) Accessible points. (i) An accessible point for a toy or article intended for children 3 years of age or less is one that can be contacted by any portion forward of the collar of the accessi-bility probe designated as probe A in figure 2 of this section.


03O

C91

.055

</G

PH

>

473


(ii) An accessible point for a toy or article intended for children over 3 years up to 8 years of age is one that can be contacted by any portion for-ward of the collar of the accessibility probe designated as probe B in figure 2 of this section.

(iii) An accessible point for a toy or article intended for children of ages spanning both age groups is one that can be contacted by any portion for-ward of the collar of either probe A or B, as shown in figure 2 of this section.

(3) Insertion depth for accessibility. (i) For any hole, recess, or opening having a minor dimension (The minor dimen-sion of an opening is the diameter of the largest sphere that will pass through the opening.) smaller than the collar diameter of the appropriate probe, the total insertion depth for ac-cessibility shall be up to the collar on the appropriate probe. Each probe joint may be rotated up to 90 degrees to sim-ulate knuckle movement.

(ii) For any hole, recess, or opening having a minor dimension larger than the collar diameter of probe A but less than 7.36 inches (186.9 millimeters), when probe A is used, or a minor di-mension larger than the collar diame-ter of probe B but less than 9.00 inches (228.6 millimeters), when probe B is used, the total insertion depth for ac-cessibility shall be determined by in-serting the appropriate probe with the extension shown in figure 2 in any di-rection up to two and one-quarter times the minor dimension of the probe, recess, or opening, measured from any point in the plane of the opening. Each probe joint may be ro-tated up to 90 degrees to simulate knuckle movement.

(iii) For any hole, recess, or opening having a minor dimension of 7.36 inches (186.9 millimeters) or larger when probe A is used, or a minor di-mension of 9.00 inches (228.6 millimeters), or larger when probe B is used, the total inser-tion depth for accessibility is unre-stricted unless other holes, recesses, or openings within the original hole, re-cess, or opening are encountered with dimensions specified in paragraph (c)(3) (i) or (ii) of this section. In such in-stances, the appropriate paragraphs (c)(3) (i) or (ii) of this section shall be followed. If both probes are to be used,

a minor dimen-sion that is 7.36 inches (186.9 millimeters or larger shall deter-mine unrestricted access.

(4) Inaccessible points. Points shall be considered inaccessible without testing with a probe if they lie adjacent to a surface of the test sample and any gap between the point and the adjacent surface does not exceed 0.020 inch (0.50 millimeter) either before or after the tests of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test—paragraph (c) of each section) are performed.

(d) Sharp point test method—(1) Prin-ciple of operation. The principle of oper-ation of the sharp point tester shown in figure 1 of this section is as follows (Detailed engineering drawings for a suggested sharp point tester are avail-able from the Commission’s Office of the Secretary.): A rectangular opening measuring 0.040 inch (1.02 millimeters) wide by 0.045 inch (1.15 millimeters) long in the end of the slotted cap estab-lishes two reference dimensions. Depth of penetration of the point being tested determines sharpness. If the point being tested can contact a sensing head that is recessed a distance of 0.015 inch (0.38 millimeter) below the end cap and can move the sensing head a further 0.005 inch (0.12 millimeter) against a 0.5-pound (2.2-newton) force of a return spring, the point shall be identified as sharp. A sharp point tester of the gen-eral configuration shown in figure 1 of this section or one yielding equivalent results shall identify a sharp point. In conducting tests to determine the pres-ence of sharp points, the Commission will use the sharp point tester shown in figure 1 of this section and the accessi-bility probes designated as A or B in figure 2 of this section.

(2) Procedure. (i) The sample to be tested shall be held in such a manner that it does not move during the test.

(ii) Part of the test sample may need to be removed to allow the sharp point testing device to test a point that is accessible by the criteria of paragraph (c) of this section. Such dismantling of the test sample could affect the rigid-ity of the point in question. The sharp point test shall be performed with the point supported so that its stiffness ap-proximates but is not greater than the point stiffness in the assembled sam-ple.


474

16 CFR Ch. II (1–1–10 Edition) § 1500.48

(iii) Using the general configuration shown in figure 1 of this section, the adjustment and operation of the sharp point tester is as follows: Hold the sharp point tester and loosen the lock ring by rotating it so that it moves to-wards the indicator lamp assembly a sufficient distance to expose the cali-bration reference marks on the barrel. Rotate the gaging can clockwise until the indicator lamp lights. Rotate the cap counterclockwise until an equiva-lent of five divisions (the distance be-tween the short lines on the cap) have passed the calibration reference mark. Lock the gaging cap in this position by rotating the lock ring until it fits firm-ly against the cap. Insert the point into the gaging slot in all directions in which it was accessible by the criteria

of paragraph (c) of this section, and apply a force of 1.00 pound (4.45 new-tons). A glowing light identifies the point as sharp.

(iv) The test instruments used by the Commission in its tests for compliance with this regulation shall have gaging slot opening dimensions no greater than 0.040 inch by 0.045 inch and shall have the sensing head recessed a depth of no less than 0.015 inch. The force ap-plied by the Commission when insert-ing a point into the gaging slot shall be no more than 1.00 pound.

(e) For the purpose of conformance with the technical requirements pre-scribed by this § 1500.48, the English fig-ures shall be used. The metric approxi-mations are provided in parentheses for convenience and information only.


475


§ 1500.49 Technical requirements for determining a sharp metal or glass edge in toys and other articles in-tended for use by children under 8 years of age.

(a) Objective. The sharp edge test method prescribed by paragraph (d) of this section will be used by the Com-

mission in making a preliminary deter-mination that metal or glass edges on toys and other articles intended for use by children under 8 years of age, and such edges exposed in normal use or as a result of reasonably forseeable dam-age or abuse of such toys and articles, present a potential risk of injury by


03O

C91

.056

</G

PH

>

476

16 CFR Ch. II (1–1–10 Edition) § 1500.49

laceration or avulsion under section 2(s) of the Federal Hazardous Sub-stances Act (15 U.S.C. 1261(s)). The Commission will further evaluate toys and other articles with edges that are identified as presenting a potential risk of laceration or avulsion injury to determine the need for individual prod-uct regulation.

(b) Scope—(1) General. The sharp edge test of paragraph (d) of this section is applicable to toys or other articles con-taining metal or glass edges that are introduced into interstate commerce after March 26, 1979. Such articles man-ufactured outside the United States are introduced into interstate commerce when first brought within as U.S. port of entry. Such articles manufactured in the United States are introduced into interstate commerce (a) at the time of first interstate sale, or (b) at the time of first intrastate sale if one or more components and/or raw materials were received interstate, whichever occurs earlier.

(2) Exemptions. (i) Toys and other children’s articles that are the subject of any of the following regulations are exempt from this § 1500.49: The regula-tions for bicycles, non-full-size baby cribs, and full-size baby cribs (parts 1508, 1509, and 1512 of this chapter).

(ii) Toys that by reason of their func-tional purpose necessarily present the hazard of sharp metal or glass edges and that do not have any nonfunc-tional sharp metal or glass edges are exempt from this section: Provided, the toy is identified by a conspicuous, leg-ible, and visible label at the time of any sale, as having functional sharp metal or glass edges. Examples of these are a pair of toy scissors and toy tool kits.

(iii) Articles, besides toys, intended for use by children that by reason of their functional purpose necessarily present the hazard of sharp metal or glass edges and that do not have any non-functional sharp metal or glass edges are exempt from this section. Ex-amples of these are children’s ice skates and children’s cutlery.

(3) Definitions—(i) Glass. For the pur-pose of this regulation the Commission defines glass as a hard, brittle, amor-phous substance produced by fusion, usually consisting of mutually dis-

solved silica and silicates that also contain soda and lime.

(ii) Metal. For the purpose of this reg-ulation the Commission intends the word metal to include both elemental metals and metal alloys.

(c) Accessibility—(1) General. Any metal or glass edge that is accessible either before or after the test of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test—paragraph (c) of each sec-tion) are performed shall be subject to the sharp edge test of paragraph (d) of this section. Toys reasonably intended to be assembled by an adult and not in-tended to be taken apart by a child shall be tested only in the assembled state if the shelf package and the as-sembly instructions prominently indi-cate that the article is to be assembled only by an adult.

(2) Accessible edges. (i) An accessible metal or glass edge for a toy or article intended for children 3 years of age or less is one that can be contacted by any portion forward of the collar of the accessibility probe designated as probe A in Figure 2 of this section.

(ii) An accessible edge for a toy or ar-ticle intended for children over 3 years and up to 8 years of age is one that can be contacted by any portion forward of the collar of the accessibility probe designated as Probe B in Figure 2 of this section.

(iii) An accessible edge for a toy or article intended for children of ages spanning both age groups is one that can be contacted by any portion for-ward of the collar of either Probe A or Probe B, as shown in Figure 2 of this section.

(3) Insertion depth. (i) For any hole, recess, or opening having a minor di-mension (the minor dimension of an opening is the diameter of the largest sphere that will pass through the open-ing), smaller than the collar diameter of the appropriate probe, the total in-sertion depth for accessibility shall be up to the collar on the appropriate probe. Each probe joint may be rotated up to 90 degrees to simulate knuckle movement.

(ii) For any hole, recess, or opening having a minor dimension larger than the collar diameter of Probe A, but less than 7.36 inches (186.9 millimeters),


477


when Probe A is used, or a minor di-mension larger than the collar diame-ter of Probe B, but less than 9.00 inches (228.6 millimeters), when Probe B is used, the total insertion depth for ac-cessibility shall be determined by in-serting the appropriate probe with the extension, shown in Figure 2, in any di-rection up to 21⁄4 times the minor di-mension of the hole, recess, or opening, measured from any point in the plane of the opening. Each probe joint may be rotated up to 90 degrees to simulate knuckle movement.

(iii) For any hole, recess, or opening having a minor dimension of 7.36 inches (186.9 millimeters) or larger when Probe A is used, or a minor dimension of 9.00 inches (228.6 millimeters) or larger when Probe B is used, the total insertion depth for accessibility is un-restricted unless other holes, recesses, or openings within the original hole, recess, or opening are encountered with dimensions specified in paragraph (c)(3) (i) or (ii) of this section. In such in-stances, the appropriate paragraphs (c)(3) (i) or (ii) of this section shall be followed. If both probes are to be used, a minor dimension that is 7.36 inches (186.9 millimeters or larger shall deter-mine unrestricted access.

(4) Inaccessible edges. Metal or glass edges shall be considered inaccessible without testing with a probe if they lie adjacent to a surface of the test sam-ple, and any gap between the edge and the adjacent surface does not exceed 0.020 inch (0.50 millimeter) both before and after the tests of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test— paragraph (c) of each section) are per-formed. For example, in a lap joint in which a metal edge is overlapped by a parallel surface, any burr or feather- edge on the side closest to the pro-tecting parallel surface is considered inaccessible if the gap between the edge and the parallel surface is no greater than 0.020 inch (0.50 milli-meter). As an additional example, when sheet metal has a hemmed edge a por-tion of the sheet adjacent to the edge is folded back upon itself, approximately 180 degrees, so that it is roughly par-allel to the main sheet. Any burrs or feathering on the inside edge, the side closest to the protecting parallel sur-face of the main sheet, will be consid-

ered inaccessible if the gap between the inside edge and the parallel surface does not exceed 0.020 inch (0.50 milli-meter).

(d) Sharp edge test method—(1) Prin-ciple of operation. The test shall be per-formed with a sharp edge tester which contains a cylindrical mandrel capable of rotation at a constant velocity. (En-gineering drawings for a suitable port-able sharp edge test instrument are available from the Commission’s Office of the Secretary.) The full circum-ference of the mandrel shall be wrapped with a single layer of poly-tetrafluoroethylene (TFE) tape as spec-ified in paragraph (e)(3) of this section. The mandrel shall be applied to the edge to be tested with a normal force of 1.35 pounds (6.00 Newtons) such that the edge contacts the approximate cen-ter of the width of the tape as shown in Figure 1 of this section. The mandrel shall be rotated through one complete revolution while maintaining the force against the edge constant. Linear mo-tion of the mandrel along the line of the edge shall be prevented. The edge shall be identified as sharp if it com-pletely cuts through the tape for a length of not less than 1⁄2 inch (13 milli-meters) at any force up to 1.35 pounds (6.00 Newtons).

(2) Procedure. (i) The edge of the sam-ple to be tested shall be held in such a manner that it does not move during the test. If the full mandrel force of 1.35 pounds (6.00 Newtons) causes the edge to bend, a reduced mandrel force may be used.

(ii) Part of the test sample may need to be removed to allow the sharp edge testing device to test an edge that is accessible by the criteria of paragraph (c) of this section. Such dismantling of the test sample could affect the rigid-ity of the edge in question. The sharp edge test shall be performed with the edge supported so that its stiffness ap-proximates but is not greater than the edge stiffness in the assembled sample.

(iii) Conduct of a sharp edge test is as follows: Wrap one layer of polytetra-fluoroethylene (TFE) tape, described in paragraph (e)(3) of this section, around the full circumference of the mandrel in an unstretched state. The ends of


478

16 CFR Ch. II (1–1–10 Edition) § 1500.49

1 The tape that the Commission will use for the sharp edge test is CHR type ‘‘T’’ manu-factured by The Connecticut Hard Rubber Co., New and East Streets, New Haven, Conn. 06509.

the tape shall be either butted or over-lapped not more than 0.10 inch (2.5 mil-limeters). Apply the mandrel, at the approximate center of the tape, to the edge of the test sample with a force of 1.35 pounds (6.00 Newtons) measured in a direction at right angles to the man-drel axis. The mandrel shall be placed so that its axis is at 90 degrees ±5 de-grees to the line of a straight test edge or 90 degrees ±5 degrees to a tangent at the point of contact with a curved test edge. The point of contact between the test edge and the mandrel shall be in the approximate center of the width of the tape. The axis of the mandrel may be positioned anywhere in a plane which is at right angles to either the line of a straight test edge or to a tan-gent at the point of contact with a curved test edge. The operator should seek the orientation most likely to cause the edge to cut the tape. Main-tain the force against the edge and ro-tate the mandrel through one complete revolution while preventing any linear motion of the mandrel along the edge. Release the mandrel from the edge and remove the tape without enlarging any cut or causing any score to become a cut. A cut in the tape with a length of not less than 1⁄2 inch (13 millimeters) identifies an edge as sharp. (The test instruments used by the Commission in its test for compliance with the regula-tion will be calibrated to insure that the force with which the mandrel is ap-plied to a test edge does not exceed 1.35 pounds.)

(e) Specifications for sharp edge test equipment. The following specifications shall apply to the equipment to be used in the sharp edge test described in paragraph (d) of this section:

(1) The rotation of the mandrel shall produce a constant tangential velocity of 1.00±0.08 inch per second (25.4±2.0 millimeters per second) during the cen-ter 75 percent of its rotation and shall have a smooth start and stop.

(2) The mandrel shall be made of steel. The test surface of the mandrel

shall be free of scratches, nicks, or burrs and shall have a surface rough-ness no greater than 16 microinches (0.40 micron). The test surface shall have a hardness no less than 40 as measured on the Rockwell ‘‘C’’ scale, as determined pursuant to ASTM E 18– 74 entitled ‘‘Standard Test Methods for Rockwell Hardness and Rockwell Su-perficial Hardness of Metallic Mate-rials,’’ published July 1974 and which is incorporated by reference in this regu-lation. (Copies are available from American Society for Testing and Ma-terials, 1916 Race Street, Philadelphia, Pa. 19103.) The diameter of the mandrel shall be 0.375±0.005 inch (9.35±0.12 milli-meters). The mandrel shall be of suit-able length to carry out the test.

(3) The tape shall be pressure-sen-sitive polytetrafluoroethylene (TFE) high temperature electrical insulation tape as described in Military Specifica-tion MIL-I-23594B (1971) which is incor-porated by reference in this regulation. (Copies are available from Naval Publi-cations and Forms Center, 5801 Tabor Ave., Philadelphia, Pa. 19120.) The thickness of the polytetrafluoro-ethylene backing shall be between 0.0026 inch (0.066 millimeter) and 0.0035 inch (0.089 millimeter). 1 The adhesive shall be pressure-sensitive silicone polymer with a nominal thickness of 0.003 inch (.08 millimeter). The width of the tape shall not be less than 1⁄4 inch (6 millimeters). While conducting sharp edge tests the temperature of the tape shall be maintained between 70 °F (21.1 °C) and 80 °F (26.6 °C).

(f) For the purpose of conformance with the technical requirements pre-scribed by this § 1500.49, the English fig-ures shall be used. The metric approxi-mations are provided in parentheses for convenience and information only.


479



03O

C91

.057

</G

PH

>

480

16 CFR Ch. II (1–1–10 Edition) § 1500.50

(Secs. 2(s), 10(a), 74 Stat. 378 (15 U.S.C. 1261, 1269))

[43 FR 12645, Mar. 24, 1978, as amended at 43 FR 21324, May 17, 1978]

§ 1500.50 Test methods for simulating use and abuse of toys and other ar-ticles intended for use by children.

(a) Objective. The objective of §§ 1500.51, 1500.52, and 1500.53 is to de-scribe specific test methods for simu-lating normal use of toys and other ar-ticles intended for use by children as well as the reasonably foreseeable dam-age or abuse to which the articles may be subjected. The test methods are for use in exposing potential hazards that would result from the normal use or the reasonably foreseeable damage or abuse of such articles intended for chil-dren.

(b) Application—general. (1)(i) The test methods described in §§ 1500.51, 1500.52 and 1500.53 are to be used in deter-mining what is normal use and reason-ably foreseeable damage or abuse when specifically referenced under § 1500.18. Other banning regulations may also reference these use and abuse toy test procedures.

(ii) The test methods described in §§ 1500.51, 1500.52, and 1500.53 have been established for articles intended for the specified age groups of children: 18 months of age or less, over 18 months but not over 36 months of age, and over 36 months but not over 96 months of


03O

C91

.058

</G

PH

>

481


1 These documents may be ordered from the General Services Administration, Specifica-tions Unit, Room 6654, 7th and D Streets, S.W., Washington, DC 20407. The price of the specification and amendment is $1.00.

age. If an article is marked, labeled, advertised, or otherwise intended for children of ages spanning more than one of these age groups, the article will be subjected to the tests providing the most stringent requirements. If an ar-ticle is not age-labeled in a clear and conspicuous manner or, based on such factors as marketing practices and the customary patterns of usage of a prod-uct by children, is inappropriately age- labeled, and is intended or appropriate for children 96 months of age or less, it will also be subjected to the most stringent test requirements.

(2) For purposes of compliance with the test methods prescribed in §§ 1500.51, 1500.52, and 1500.53, the English system shall be used. The met-ric approximations are provided in pa-rentheses for convenience and informa-tion only.

(3) Each of the test methods de-scribed in §§ 1500.51, 1500.52, and 1500.53 shall be applied to a previously untest-ed sample except the tension test which shall be conducted with the test sample used in the torque test.

(4) Prior to testing, each sample shall be subjected to a temperature of 73°±3 °F. (23°±2 °C.) as a relative humidity of 20¥70 percent for a period of at least 4 hours. The toy testing shall commence within five minutes after the toy has been removed from the preconditioning atmosphere.

(5) Toys reasonably intended to be as-sembled by an adult and not intended to be taken apart by a child shall be tested only in the assembled state if the shelf package and the assembly in-structions prominently indicate that the article is to be assembled only by an adult.

(6) Toys intended to be repeatedly as-sembled and taken apart shall have the individual pieces as well as the com-pleted article subjected to these test procedures.

(7) In situations where a test proce-dure may be applied in more than one way to a toy test component, the point (or direction) of force (or torque) appli-cation which results in the most severe conditions shall be used.

(c) Definitions. As used in this section and in §§ 1500.51, 1500.52, and 1500.53:

(1) Toy means any toy, game, or other article designed, labeled, adver-

tised, or otherwise intended for use by children.

(2) Mouth toy means any toy reason-ably intended to be placed into or in contact with a child’s mouth.

[40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. 10, 1975]

§ 1500.51 Test methods for simulating use and abuse of toys and other ar-ticles intended for use by children 18 months of age or less.

(a) Application. The test methods de-scribed in this section shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use by children 18 months of age or less in conjunction with § 1500.18.

(b) Impact test—(1) Application. Except as provided in paragraph (b)(4) of this section, toys having a weight of less than 3.0 pounds ±0.01 pound (1.4 kilo-grams) shall be subject to this test.

(2) Impact medium. The impact me-dium shall consist of a 1⁄8-inch (0.3-cen-timeter) nominal thickness of type IV vinyl-composition tile, composition 1— asbestos free, as specified by para-graphs 1.2 and 3.1.4 of Interim Amend-ment-1(YD), dated November 14, 1979, to the Federal Specification entitled Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-Asbestos, SS-T-312B, dated Octo-ber 10, 1974, 1 over at least a 2.5-inch (6.4-centimeter) thickness of concrete. The impact area shall be at least 3 square feet (0.3 square meter). The Commission recognizes that this speci-fied impact medium is the equivalent of, and will yield the same impact test results as, a surface covered with vinyl-asbestos tile meeting the require-ments of Federal Specification SS-T- 312A.

(3) Testing procedure. Except as pro-vided in paragraphs (b)(4) (i) and (ii) of this section, the toy shall be dropped 10 times from a height of 4.5 feet ±0.5 inch (1.37 meters) onto the impact medium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop,


482

16 CFR Ch. II (1–1–10 Edition) § 1500.51

the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.

(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square cen-timeters), shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. The base area for toys with permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.

(ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic meter), calculated by the major dimensions without regard to minor appendages, shall be tested for impact in accord-ance with paragraph (b)(4)(iii) of this section.

(iii) The toys described in paragraph (b)(4)(i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (or component or any accessible portion thereof) that has an external dimen-sion of 1.25 inches ±0.05 inch (3.18 centi-meters) or less and a design configura-tion that would permit a child to insert a portion into the mouth in any ori-entation up to a biting thickness of 1.25 inches ±0.05 inch (3.18 centimeters), for a penetration of at least 0.25 inch (0.635 centimeter), shall be subject to this test.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall be two metal strips or plates each meas-uring 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.05 centimeter), for at least a 150-degree cross-sectional arc. A suggested con-tact mechanism appears in figure 1 of this section.

(ii) Loading device. The loading device shall be a scale or force gauge having an accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The test article shall be placed in the contact mecha-nism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position uti-lizes less than 180 degrees of the arc of

the contact mechanism, and a test load increasing to 25 pounds ±0.5 pound (11.35 kilograms) shall be evenly ap-plied within 5 seconds. This load shall be maintained for an additional 10 sec-onds.

(d) Flexure test—(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or other metal material(s), for stiffening or for retention of form if the compo-nent can be bent through a 60-degree arc by a maximum force of 10 pounds ±0.5 pound (4.55 kilograms), applied per-pendicularly to the major axis of the component at a point 2 inches (5 centi-meters) from the intersection of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.

(2) Testing procedure. The toy shall be secured in a vise equipped with vise shields that are fabricated from 13- gauge cold-rolled steel or other similar material and that have a 0.375-inch (0.95-centimeter) inside radius. The component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches ±0.05 inch (5 centimeters) from the intersec-tion of the component with the main body of the toy or applied at the end of the component if the component is less than 2 inches (5 centimeters) long. The component shall then be bent in the re-verse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period oc-curring after each 10 cycles. Two 120- degree arc bends shall constitute one cycle.

(e) Torque test—(1) Application—(i) General. A toy with a projection, part, or assembly that a child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test.

(ii) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on an accessible rod or shaft designed to rotate along with the projections, parts, or assem-blies shall be tested with the rod or shaft clamped to prevent rotation.

(2) Test equipment—(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appro-priate device having an accuracy of ±0.2


483


inch-pound (±0.23 kilogram-centi-meter).

(ii) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force.

(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of 2 inch-pounds ±0.2 inch-pound (2.30 kilo-gram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 2 inch-pounds (2.30 kilogram-centimeters) exceeded. The torque or maximum rotation shall be maintained for an additional 10 sec-onds. The torque shall then be removed and the test component permitted to return to a relaxed condition. This pro-cedure shall then be repeated in a counterclockwise direction.

(f) Tension test—(1) Application—(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test de-scribed in paragraph (e) of this section.

(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams sub-jected to 10 pounds ±0.5 pound (4.55 kilograms) of force applied in any di-rection.

(2) Test equipment—(i) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required.

(ii) Loading device. The loading device is to be a self-indicating gauge or other

appropriate means having an accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. With the test sample fastened in a convenient posi-tion, an appropriate clamp shall be at-tached to the test object or component. A 10-pound ±0.5 pound (4.55–kilogram) direct force shall be evenly applied, within a period of 5 seconds, parallel to the major axis of the test component and maintained for an additional 10 seconds. The tension clamp shall then be removed and a second clamp appro-priate for pulling at 90 degrees shall be attached to the test object or compo-nent. A 10-pound ±0.5 pound (4.55-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of the test component and maintained for an additional 10 seconds.

(g) Compression test—(1) Application. Any area on the surface of a toy that is accessible to a child and inaccessible to flat-surface contact during the impact test shall be subject to this test.

(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diame-ter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1⁄32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The disc shall be positioned so that the contact surface is parallel to the surface under test. A direct force of 20 pounds ±0.5 pound (9.1 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an addi-tional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.


484

16 CFR Ch. II (1–1–10 Edition) § 1500.52

[40 FR 1484, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975; 40 FR 17746, Apr. 22, 1975; as amended at 55 FR 52040, Dec. 19, 1990; 56 FR 9, Jan. 2, 1991; 56 FR 558, Jan. 7, 1991]

§ 1500.52 Test methods for simulating use and abuse of toys and other ar-ticles intended for use by children over 18 but not over 36 months of age.

(a) Application. The test methods de-scribed in this section, shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use

by children over 18 but not over 36 months of age in conjunction with § 1500.18.



03O

C91

.059

</G

PH

>

485


1 See footnote 1 to § 1500.51.


(3) Testing procedure. Except as pro-vided in paragraph (b)(4) (i) and (ii) of this section, the toy shall be dropped four times from a height of 3 feet ±0.5 inch (0.92 meter) onto the impact me-dium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop, the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.

(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square cen-timeters) shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. The base area for toys with permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.


(iii) The toys described in paragraph (b)(4) (i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (or component or any accessible portion thereof) that has an external dimen-sion of 1.25 inches ±0.05 inch (3.18 centi-meters) or less and a design configura-tion that would permit a child to insert a portion into the mouth in any ori-entation up to a biting thickness of 1.25 inches ±0.05 inches (3.18 centimeters), for a penetration of at least 0.25 inch (0.635 centimeter), shall be subject to this test.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall be two metal strips or plates each meas-uring 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.05 centimeter) for at least a 150-degree cross-sectional arc. A suggested con-tact mechanism appears in figure 1 of § 1500.51.


(3) Testing procedure. The test article shall be placed in the contact mecha-nism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position uti-lizes less than 180 degrees of the arc of the contact mechanism, and a test load increasing to 50 pounds ±0.5 pound (22.74 kilograms) shall be evenly ap-plied within 5 seconds. This load shall be maintained for an additional 10 sec-onds.

(d) Flexure test—(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or other metal material(s), for stiffening or for retention of form if the compo-nent can be bent through a 60-degree arc by a maximum force of 15 pounds ±0.5 pound (6.80 kilograms) applied per-pendicularly to the major axis of the component at a point 2 inches ±0.05 inch (5 centimeters) from the intersec-tion of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.

(2) Testing procedure. The toy shall be secured in a vise equipped with vise shields that are fabricated from 13- gauge cold-rolled steel or other similar material and that have a 0.375-inch (0.95-centimeter) inside radius. The


486

16 CFR Ch. II (1–1–10 Edition) § 1500.52

component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches ±0.05 inch (5 centimeters) from the intersec-tion of the component with the main body of the toy or applied at the end of the component if the component is less than 2 inches (5 centimeters) long. The component shall then be bent in the re-verse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period oc-curring after each 10 cycles. Two 120- degree arc bends shall constitute one cycle.



(2) Test equipment—(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appro-priate device having an accuracy of ±0.2 inch-pound (±0.23 kilogram-centi-meter).


(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of 3 inch-pounds ±0.2 inch-pound (3.46 kilo-gram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 3 inch-pounds ±0.2 inch-pound (3.46 kilogram-centimeters) exceeded. The torque or maximum ro-tation shall be maintained for an addi-tional 10 seconds. The torque shall then be removed and the test component permitted to return to a relaxed condi-tion. This procedure shall then be re-peated in a counterclockwise direction.

(f) Tension test—(1) Application—(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall

be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test de-scribed in paragraph (e) of this section.



(ii) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of ±0.5 pound (±255 grams).

(3) Testing procedure. With the test sample fastened in a convenient posi-tion, an appropriate clamp shall be at-tached to the test object or component. A 15-pound ±0.5 pound (6.80-kilogram) direct force shall be evenly applied, within a period of 5 seconds, parallel to the major axis of the test component and maintained for an additional 10 seconds. The tension clamp shall then be removed and a second clamp appro-priate for pulling at 90 degrees shall be attached to the test object or compo-nent. A 15-pound ±0.5 pound (6.80-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of the test component and maintained for an additional 10 seconds.


(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diame-ter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1⁄32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accurancy of ±0.5 pound (±225 grams).

(3) Testing procedure. The disc shall be positioned so that the contact surface


487


is parallel to the surface under test. A direct force of 25 pounds ±0.5 pound (11.4 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an addi-tional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.

[40 FR 1485, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975; as amended at 56 FR 10, Jan. 2, 1991]

§ 1500.53 Test methods for simulating use and abuse of toys and other ar-ticles intended for use by children over 36 but not over 96 months of age.

(a) Application. The test methods de-scribed in this section shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use by children over 36 but not over 96 months of age in conjunction with § 1500.18.



(3) Testing procedure. except as pro-vided in paragraph (b)(4) (i) and (ii) of this section, the toy shall be dropped four times from a height of 3 feet ±0.5 inch (0.92 meter) onto the impact me-dium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop,

the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.

(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square cen-timeters) shall be tested for impact in accordance with paragraph (b)(4)(iii) of this subsection. The base area for toys having permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.


(iii) The toys described in paragraph (b)(4) (i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (or component) that is a mouth toy shall be subject to this test.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall be two metal strips or plates each meas-uring 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.5 centimeter) for at least a 150-degree cross-sectional arc. A suggested con-tact mechanism appears in figure 1 of § 1500.51.


(3) Testing procedure. The test article shall be placed in the contact mecha-nism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position uti-lizes less than 180 degrees of the arc of the contract mechanism, and a test load increasing to 100 pounds ±0.5 pound (45.50 kilograms) shall be evenly applied within 5 seconds. This load shall be maintained for an additional 10 seconds.

(d) Flexure test—(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or


488

16 CFR Ch. II (1–1–10 Edition) § 1500.53

other metal material(s), for stiffening or for retention of form if the compo-nent can be bent through a 60-degree arc by a maximum force of 15 pounds ±0.5 pound (6.80 kilograms) applied per-pendicularly to the major axis of the component at a point 2 inches ±0.05 inch (5 centimeters) from the intersec-tion of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.

(2) Testing procedure. The toy shall be secured in a vise equipped with vise shields that are fabricated from 13- gauge cold-rolled steel or other similar material and that have a 0.375-inch (0.95-centimeter) inside radius. The component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches (5 cen-timeters) from the intersection of the component with the main body of the toy or applied at the end of the compo-nent if the component is less than 2 inches (5 centimeters) long. The com-ponent shall then be bent in the re-verse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period oc-curring after each 10 cycles. Two 120- degree arc bends shall constitute one cycle.



(2) Test equipment—(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appro-priate device having an accuracy of ±0.2 inch-pound (±0.23 kilogram-centi-meter).


(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the

test object or component. A torque of 4 inch-pounds ±0.2 inch-pound (4.60 kilo-gram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 4 inch-pounds ±0.2 inch-pound (4.60 kilogram-centimeters) exceeded. The torque or maximum ro-tation shall be maintained for an addi-tional 10 seconds. The torque shall then be removed and the test component permitted to return to a relaxed condi-tion. This procedure shall then be re-peated in a counterclockwise direction.

(f) Tension test—(1) Application—(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test de-scribed in paragraph (e) of this section.



(ii) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. With the test sample fastened in a convenient posi-tion, and appropriate clamp shall be at-tached to the test object or component. A 15-pound ±0.5 pound (6.80-kilogram) direct force shall be evenly applied, within a period of 5 seconds, parallel to the major axis of the test component and maintained for an additional 10 seconds. The tension clamp shall then be removed and a second clamp appro-priate for pulling at 90 degrees shall be attached to the test object or compo-nent. A 15-pound ±0.5 pound (6.80-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of the


489


test component and maintained for an additional 10 seconds.


(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diame-ter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1⁄32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The disc shall be positioned so that the contact surface is parallel to the surface under test. A direct force of 30 pounds ±0.5 pound (13.6 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an addi-tional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.

[40 FR 1486, Jan. 7, 1975; 40 FR 16192, Apr. 10, 1975, as amended at 56 FR 10, Jan. 2, 1991]

§ 1500.81 Exemptions for food, drugs, cosmetics, and fuels.

(a) Food, drugs, and cosmetics. Sub-stances subject to the Federal Food, Drug, and Cosmetic Act are exempted by section 2(f)(2) of the act; but where a food, drug, or cosmetic offers a sub-stantial risk of injury or illness from any handling or use that is customary or usual it may be regarded as mis-branded under the Federal Food, Drug, and Cosmetic Act because its label fails to reveal material facts with re-spect to consequences that may result from use of the article (21 U.S.C. 321(n)) when its label fails to bear information to alert the householder to this hazard.

(b) Fuels. A substance intended to be used as a fuel is exempt from the re-quirements of the act when in con-tainers that are intended to be or are installed as part of the heating, cool-ing, or refrigeration system of a house. A portable container used for delivery or temporary or additional storage, and containing a substance that is a hazardous substance as defined in sec-tion 2(f) of the act, is not exempt from the labeling prescribed in section 2(p)

of the act, even though it contains a fuel to be used in the heating, cooking, or refrigeration system of a house.

§ 1500.82 Exemption from full labeling and other requirements.

(a) Any person who believes a par-ticular hazardous substance intended or packaged in a form suitable for use in the household or by children should be exempted from full label compliance otherwise applicable under the act, be-cause of the size of the package or be-cause of the minor hazard presented by the substance, or for other good and sufficient reason, may submit to the Commission a request for exemption under section 3(c) of the act, presenting facts in support of the view that full compliance is impracticable or is not necessary for the protection of the pub-lic health. The Commission shall deter-mine on the basis of the facts sub-mitted and all other available informa-tion whether the requested exemption is consistent with adequate protection of the public health and safety. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order pub-lished in the FEDERAL REGISTER.

(b) The Commission may on its own initiative determine on the basis of facts available to it that a particular hazardous substance intended or pack-aged in a form suitable for use in the household or by children should be ex-empted from full labeling compliance otherwise applicable under the act be-cause of the size of the package or be-cause of the minor hazard presented by the substance or for other good and sufficient reason. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order in the FEDERAL REG-ISTER.

(c) Any person who believes a par-ticular article should be exempted from being classified as a ‘‘banned haz-ardous substance’’ as defined by sec-tion 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)), because its func-tional purpose requires inclusion of a hazardous substance, it bears labeling giving adequate directions and warn-ings for safe use, and it is intended for use by children who have attained suf-ficient maturity, and may reasonably


490

16 CFR Ch. II (1–1–10 Edition) § 1500.83

be expected, to read and heed such di-rections and warnings, may submit to the Commission a request for exemp-tion under section 2(q)(1)(B)(i) of the act (repeated in proviso (1) under § 1500.3(b)(15(i)), presenting facts in sup-port of his contention. The commission shall determine on the basis of the facts submitted, and all other available information, whether the requested ex-emption is consistent with the pur-poses of the act. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order in the FEDERAL REG-ISTER.

(d) On its own initiative, the Com-mission may determine on the basis of available facts that a particular banned hazardous substance should be exempted from section 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)), be-cause its functional purpose requires inclusion of a hazardous substance, it bears labeling giving adequate direc-tions and warnings for safe use, and it is intended for use by children who have obtained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings. If the Commission so finds, it shall de-tail the exemption granted and the rea-sons therefor by an appropriate order in the FEDERAL REGISTER.

§ 1500.83 Exemptions for small pack-ages, minor hazards, and special circumstances.

(a) The following exemptions are granted for the labeling of hazardous substances under the provisions of § 1500.82:

(1) When the sole hazard from a sub-stance in a self-pressurized container is that it generates pressure or when the sole hazard from a substance is that it is flammable or extremely flammable, the name of the component which con-tributes the hazards need not be stated.

(2) Common matches, including book matches, wooden matches, and so- called ‘‘safety’’ matches are exempt from the labeling requirements of sec-tion 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the product being considered haz-ardous because of being ‘‘flammable’’ or ‘‘extremely flammable’’ as defined in § 1500.3(c)(6)(iii) and (iv).

(3) Paper items such as newspapers, wrapping papers, toilet and cleansing tissues, and paper writing supplies are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the products being considered haz-ardous because of being ‘‘flammable’’ or ‘‘extremely flammable’’ as defined in § 1500.3(c)(6)(iii) and (iv).

(4) Thread, string, twine, rope, cord, and similar materials are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the products being considered haz-ardous because of being ‘‘flammable’’ or ‘‘extremely flammable’’ as defined in § 1500.3(c)(6) (iii) and (iv).

(5) Laboratory chemicals intended only for research or investigational and other laboratory uses (except those in home chemistry sets) are exempt from the requirements of placement provided in § 1500.121 if all information required by that section and the act appears with the required prominence on the label panel adjacent to the main panel.

(6) [Reserved] (7) Rigid or semirigid ballpoint ink

cartridges are exempt from the label-ing requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), insofar as such requirements would be necessary because the ink contained therein is a ‘‘toxic’’ substance as de-fined in § 1500.3(c)(2)(i), if:

(i) The ballpoint ink cartridge is of such construction that the ink will, under any reasonably foreseeable con-ditions of manipulation or use, emerge only from the ballpoint end;

(ii) When tested by the method de-scribed in § 1500.3(c)(2)(i), the ink does not have an LD–50 single oral dose of less than 500 milligrams per kilogram of body weight of the test animal; and

(iii) The cartridge does not have a ca-pacity of more than 2 grams of ink.

(8) Containers of paste shoe waxes, paste auto waxes, and paste furniture and floor waxes containing toluene (also known as toluol), xylene (also known as xylol), petroleum distillates, and/or turpentine in the concentrations described in § 1500.14(a)(3) and (5) are exempt from the labeling requirements of § 1500.14(b)(3)(ii) and (5) if the


491


visicosity of such products is suffi-ciently high so that they will not flow from their opened containers when in-verted for 5 minutes at a temperature of 80 °F., and are exempt from bearing a flammability warning statement if the flammability of such waxes is due solely to the presence of solvents that have flashpoints above 80 °F. when tested by the method described in § 1500.43.

(9) Porous-tip ink-marking devices are exempt from the labeling require-ments of section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)) and from the labeling requirements of § 1500.14(b)(1), (2), and (3)(ii) and (iii) insofar as such requirements would be necessary be-cause the ink contained therein is a toxic substance as defined in § 1500.3(c)(2)(i), and/or because the ink contains 10 percent or more by weight of toluene (also known as toluol), xy-lene (also known as xylol), or petro-leum distillates as defined in § 1500.14(a)(3), and/or because the ink contains 10 percent or more by weight of ethylene glycol; provided that:

(i) The porous-tip ink-marking de-vices are of such construction that:

(A) The ink is held within the device by an absorbent material so that no free liquid is within the device; and

(B) Under any reasonably foreseeable conditions of manipulation and use, in-cluding reasonably foreseeable abuse by children, the ink will emerge only through the porous writing nib of the device; and

(ii)(A) The device has a capacity of not more than 10 grams of ink and the ink, when tested by methods described in § 1500.3(c)(2)(i), has an LD–50 single oral dose of not less than 2.5 grams per kilogram of body weight of the test animal; or

(B) The device has a capacity of not more than 12 grams of ink and the ink, when tested by methods described in § 1500.3(c)(2)(i), has an LD–50 single oral dose of not less than 3.0 grams per kilo-gram of body weight of the test animal.

(10) Viscous nitrocellulose-base adhe-sives containing more than 4 percent methyl alcohol by weight are exempt from the label statement ‘‘Cannot be be made nonpoisonous’’ required by § 1500.14(b)(4) if:

(i) The total amount of methyl alco-hol by weight in the product does not exceed 15 percent; and

(ii) The contents of any container does not exceed 2 fluid ounces.

(11) Packages containing polishing or cleaning products which consist of a carrier of solid particulate or fibrous composition and which contain toluene (also known as toluol), xylene (also known as xylol), or petroleum dis-tillates in the concentrations described in § 1500.14(a) (1) and (2) are exempt from the labeling requirements of § 1500.14(b)(3)(ii) if such toluene, xylene, or petroleum distillate is fully ab-sorbed by the solid, semisolid, or fi-brous carrier and cannot be expressed therefrom with any reasonably foresee-able conditions of manipulation.

(12) Containers of dry ink intended to be used as a liquid ink after the addi-tion of water are exempt from the la-beling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and from the labeling requirements of § 1500.14(b) (1) and (2) insofar as such re-quirements would be necessary because the dried ink contained therein is a toxic substance as defined in § 1500.3(c)(2)(i) and/or because the ink contains 10 percent or more of ethylene glycol as defined in § 1500.14(a)(2); pro-vided that:

(i) When tested by the method de-scribed in § 1500.3(c)(2)(i), the dry ink concentrate does not have an LD–50 (le-thal dose, median; lethal for 50 percent or more of test group) single oral dose of less than 1 gram per kilogram of body weight of the test animal.

(ii) The dry ink concentrate enclosed in a single container does not weigh more than 75 milligrams.

(iii) The dry ink concentrate does not contain over 15 percent by weight of ethylene glycol.

(13) Containers of liquid and semi-solid substances such as viscous-type paints, varnishes, lacquers, roof coat-ings, rubber vulcanizing preparations, floor covering adhesives, glazing com-pounds, and other viscous products containing toluene (also known as tol-uol), xylene (also known as xylol), or petroleum distillates in concentrations described in § 1500.14(a)(3) are exempt from the labeling requirements of


492

16 CFR Ch. II (1–1–10 Edition) § 1500.83

§ 1500.14(b)(3)(ii) insofar as that subdivi-sion applies to such toluene, xylene, or petroleum distillates, provided that the viscosity of the substance or of any liq-uid that may separate or be present in the container is not less than 100 Saybolt universal seconds at 100 °F.

(14) Customer-owned portable con-tainers that are filled by retail vendors with gasoline, kerosene (kerosine), or other petroleum distillates are exempt from the provision of section 2(p)(1)(A) of the act (which requires that the name and place of business of the man-ufacturer, distributor, packer, or seller appear on the label of such containers) provided that all the other label state-ments required by section 2(p)(1) of the act and § 1500.14(b)(3) appear on the la-bels of containers of the substances named in this subparagraph.

(15) Cellulose sponges are exempt from the labeling requirements of sec-tion 2(p)(1) of the act and § 1500.14(b)(1) insofar as such requirements would be necessary because they contain 10 per-cent or more of diethylene glycol as de-fined in § 1500.14(a)(1), provided that:

(i) The cellulose sponge does not con-tain over 15 percent by weight of diethylene glycol; and

(ii) The diethylene glycol content is completely held by the absorbent cel-lulose material so that no free liquid is within the sponge as marketed.

(16) Containers of substances which include salt (sodium chloride) as a component are exempt from the label-ing requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) in-sofar as such requirements would be necessary because the salt contained therein is present in a quantity suffi-cient to render the article ‘‘toxic’’ as defined in § 1500.3(3)(2)(i), provided that the labels of such containers bear a conspicuous statement that the prod-uct contains salt.

(17) The labeling of substances con-taining 10 percent or more of ferrous oxalate is exempt from the require-ment of § 1500.129(f) that it bear the word ‘‘poison’’ which would be required for such concentration of a salt of ox-alic acid.

(18) Packages containing articles in-tended as single-use spot removers, and which consist of a cotton pad or other absorbent material saturated with a

mixture of drycleaning solvents, are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the ‘‘flammable’’ hazard as defined in § 1500.3(c)(6)(iv), provided that:

(i) The article is packaged in a sealed foil envelope;

(ii) The total amount of solvent in each package does not exceed 4.5 milli-liters; and

(iii) The article will ignite only when in contact with an open flame, and when so ignited, the article burns with a sooty flame.

(19) Packages containing articles in-tended as single-use spot removers, and which consist of a cotton pad or other absorbent material containing methyl alcohol, are exempt from the labeling requirements of § 1500.14(b)(4), if:

(i) The total amount of cleaning sol-vent in each package does not exceed 4.5 milliliters of which not more than 25 percent is methyl alcohol; and

(ii) The liquid is completely held by the absorbent materials so that no free liquid is within the packages mar-keted.

(20) Cigarette lighters containing pe-troleum distillate fuel are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and § 1500.14(b)(3) inso-far as such requirements would be nec-essary because the petroleum distillate contained therein is flammable and be-cause the substance is named in § 1500.14(a)(3) as requiring special label-ing, provided that:

(i) Such lighters contain not more than 10 cubic centimeters of fuel at the time of sale; and

(ii) Such fuel is contained in a sealed compartment that cannot be opened without the deliberate removal of the flush-set, screw-type refill plug of the lighter.

(21) Containers of dry granular fer-tilizers and dry granular plant foods are exempt from the labeling require-ments of section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)) insofar as such requirements would be necessary because the fertilizer or plant food con-tained therein is a toxic substance as defined in § 1500.3(c)(2)(i), provided that:

(i) When tested by the method de-scribed in § 1500.3(c)(2)(i), the product


493


has a single dose LD–50 of not less than 3.0 grams per kilogram of body weight of the test animal;

(ii) The label of any such exempt dry granular fertilizers discloses the iden-tity of each of the hazardous ingredi-ents;

(iii) The label bears the name and ad-dress of the manufacturer, packer, dis-tributor, or seller; and

(iv) The label bears the statement ‘‘Keep out of the reach of children’’ or its practical equivalent.

(22) Small plastic capsules containing a paste composed of powdered metal solder mixed with a liquid flux are ex-empt from the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if:

(i) The capsule holds not more than one-half milliliter of the solder mix-ture;

(ii) The capsule is sold only as a com-ponent of a kit; and

(iii) Adequate caution statements ap-pear on the carton of the kit and on any accompanying labeling which bears directions for use.

(23) Chemistry sets and other science education sets intended primarily for use by juveniles, and replacement con-tainers of chemicals for such sets, are exempt from the requirements of sec-tion 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if:

(i) The immediate container of each chemical that is hazardous as defined in the act and regulations thereunder bears on its main panel the name of such chemical, the appropriate signal word for that chemical, and the addi-tional statement ‘‘Read back panel be-fore using’’ (or ‘‘Read side panel before using,’’ if appropriate) and bears on the back (or side) panel of the immediate container the remainder of the appro-priate cautionary statement for the specific chemical in the container;

(ii) The experiment manual or other instruction book or booklet accom-panying such set bears on the front page thereof, as a preface to any writ-ten matter in it (or on the cover, if any there be), the following caution state-ment within the borders of a rectangle and in the type size specified in § 1500.121:

WARNING—This set contains chemi-cals that may be harmful if misused.

Read cautions on individual containers carefully. Not to be used by children except under adult supervision

; and (iii) The outer carton of such set

bears on the main display panel within the borders of a rectangle, and in the type size specified in § 1500.121, the cau-tion statement specified in paragraph (a)(23)(ii) of this section.

(24) Fire extinguishers containing fire extinguishing agents which are stored under pressure or which develop pressure under normal conditions of use are exempt from the labeling re-quirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements apply to the pres-sure hazard as defined in § 1500.3(c)(7)(i), provided that:

(i) If the container is under pressure both during storage and under condi-tions of use, it shall be designed to withstand a pressure of at least 6 times the charging pressure at 70 °F., except that carbon dioxide extinguishers shall be constructed and tested in accord-ance with applicable Interstate Com-merce Commission specifications; or

(ii) If the container is under pressure only during conditions of use, it shall be designed to withstand a pressure of not less than 5 times the maximum pressure developed under closed nozzle conditions at 70 °F. or 11⁄2 times the maximum pressure developed under closed nozzle conditions at 120 °F., whichever is greater.

(25) Cleaning and spot removing kits intended for use in cleaning carpets, furniture, and other household objects; kits intended for use in coating, paint-ing, antiquing, and similarly proc-essing furniture, furnishings, equip-ment, sidings, and various other sur-faces; and kits intended for use in pho-tographic color processing are exempt from the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and from the requirements of § 1500.14, provided that:

(i) The immediate container of each hazardous substance in the kit is fully labeled and in conformance with the requirements of the act and regula-tions thereunder; and

(ii) The carton of the kit bears on the main display panel (or panels) within a


494

16 CFR Ch. II (1–1–10 Edition) § 1500.83

borderline, and in the type size speci-fied in § 1500.121, the caution statement ‘‘(Insert proper signal word as specified in paragraph (a)(25)(iii) of this section). This kit contains the following chemi-cals that may be harmful if misused: (List hazardous chemical components by name.) Read cautions on individual containers carefully. Keep out of the reach of children.’’

(iii) If either the word ‘‘POISON’’ or ‘‘DANGER’’ is required on the con-tainer of any component of the kit, the same word shall be required to appear as part of the caution statement on the kit carton. If both ‘‘POISON’’ and ‘‘DANGER’’ are required in the label-ing of any component or components in the kit, the word ‘‘POISON’’ shall be used. In all other cases the word ‘‘WARNING’’ or ‘‘CAUTION’’ shall be used.

(26) Packages containing articles in-tended as single-use spot removers and containing methyl alcohol are exempt from the labeling specified in § 1500.14(b)(4), if:

(i) The total amount of cleaning sol-vent in each unit does not exceed 1 mil-liliter, of which not more than 40 per-cent is methyl alcohol;

(ii) The liquid is contained in a sealed glass ampoule enclosed in a plastic container with a firmly at-tached absorbent wick at one end through which the liquid from the crushed ampoule must pass, under the contemplated conditions of use; and

(iii) The labeling of each package of the cleaner bears the statement ‘‘WARNING—Keep out of the reach of children,’’ or its practical equivalent, and the name and place of business of the manufacturer, packer, distributor, or seller.

(27) Packaged fireworks assortments intended for retail distribution are ex-empt from section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)), if:

(i) The package contains only fire-works devices suitable for use by the public and designed primarily to produce visible effects by combustion, except that small devices designed to produce audible effects may also be in-cluded if the audible effect is produced by a charge of not more than 2 grains of pyrotechnic composition;

(ii) Each individual article in the as-sortment is fully labeled and in con-formance with the requirements of the act and regulations thereunder; and

(iii) The outer package bears on the main display panel (or panels), within the borders of a rectangle and in the type size specified in § 1500.121, the cau-tion statement ‘‘WARNING—This as-sortment contains items that may be hazardous if misused and should be used only under adult supervision. IM-PORTANT—Read cautions on indi-vidual items carefully.’’ (See also § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); § 1500.85(a)(2); and part 1507).

(28) Packages containing felt pads impregnated with ethylene glycol are exempt from the labeling requirements of § 1500.14(b)(1), if:

(i) The total amount of ethylene gly-col in each pad does not exceed 1 gram; and

(ii) The liquid is held by the felt pad so that no free ethylene glycol is with-in the package.

(29) Cigarette lighters containing bu-tane and/or isobutane fuel are exempt from the labeling requirements of sec-tion 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such require-ments would otherwise be necessary because the fuel therein is extremely flammable and under pressure, pro-vided that:

(i) The lighters contain not more than 12 grams of fuel at the time of sale; and

(ii) The fuel reservoir is designed to withstand a pressure of at least 11⁄2 times the maximum pressure which will be developed in the container at 120 °F.

(30) The outer retail containers of solder kits each consisting of a small tube of flux partially surrounded by a winding of wire-type cadmium-free sil-ver solder are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if:

(i) The metal solder contains no cad-mium and is not otherwise hazardous under the provisions of the act;

(ii) The tube of flux in the kit is fully labeled and in conformance with the act and regulations thereunder, and any accompanying literature that bears directions for use also bears all


495


the information required by section 2(p) of the act; and

(iii) The main panel of the outer con-tainer bears in type size specified in § 1500.121 the following: (A) The signal word; (B) a statement of principal haz-ard or hazards; (C) the statement ‘‘Keep out of the reach of children,’’ or its practical equivalent; and (D) in-structions to read other cautionary in-structions on the tube of flux within.

(31) Visual novelty devices consisting of sealed units, each of which unit is a steel and glass cell containing perchloroethylene (among other things), are exempt from the require-ments of § 1500.121(a) that would other-wise require a portion of the warning statement to appear on the glass face of the device, provided that:

(i) The device contains not more than 105 milliliters of perchloroethylene and contains no other component that con-tributes substantially to the hazard; and

(ii) The following cautionary state-ment appears on the device (other than on the bottom) in the type size speci-fied in § 1500.121 (c) and (d):

CAUTION—IF BROKEN, RESULTANT VAPORS MAY BE HARMFUL

Contains perchloroethylene. Do not expose to extreme heat. If broken indoors, open win-dows and doors until all odor of chemical is gone.

Keep out of the reach of children.

A practical equivalent may be sub-stituted for the statement ‘‘Keep out of the reach of children.’’

(32) Hollow plastic toys containing mineral oil are exempt from the label-ing specified in § 1500.14(b)(3)(ii), if:

(i) The article contains no other in-gredient that would cause it to possess the aspiration hazard specified in § 1500.14(b)(3)(ii);

(ii) The article contains not more than 6 fluid ounces of mineral oil;

(iii) The mineral oil has a viscosity of at least 70 Saybolt universal seconds at 100 °F.;

(iv) The mineral oil meets the speci-fications in the N.F. for light liquid petrolatum; and

(v) The container bears the state-ment ‘‘CAUTION—Contains light liquid petrolatum N.F. Discard if broken or leak develops.’’

(33) Containers of mineral oil having a capacity of not more than 1 fluid ounce and intended for use in pro-ducing a smoke effect for toy trains are exempt from the labeling specified in § 1500.14(b)(3), if:

(i) The mineral oil meets the speci-fications in the N.F. for light liquid petrolatum;

(ii) The mineral oil has a viscosity of at least 130 Saybolt universal seconds at 100 °F.;

(iii) The article contains no other in-gredient that contributes to the haz-ard; and

(iv) The label declares the presence light liquid petrolatum and the name and place of business of the manufac-turer, packer, distributor, or seller.

(34) Viscous products containing more than 4 percent by weight of meth-yl alcohol, such as adhesives, asphalt- base roof and tank coatings, and simi-lar products, are exempt from bearing the special labeling required by § 1500.14(b)(4), if:

(i) The product contains not more than 15 percent by weight of methyl al-cohol;

(ii) The methyl alcohol does not sepa-rate from the other ingredients upon standing or through any foreseeable use or manipulation;

(iii) The viscosity of the product is not less than 7,000 centipoises at 77 °F., unless the product is packaged in a pressurized container and is dispensed as a liquid unsuitable for drinking; and

(iv) The labeling bears the statement ‘‘Contains methyl alcohol. Use only in well-ventilated area. Keep out of the reach of children.’’

(35) Individual detonators or blasting caps are exempt from bearing the statement, ‘‘Keep out of the reach of children,’’ or its practical equivalent, if:

(i) Each detonator or cap bears con-spicuously in the largest type size practicable the statement, ‘‘DAN-GEROUS—BLASTING CAPS—EXPLO-SIVE’’ or ‘‘DANGEROUS—DETO-NATOR—EXPLOSIVE’’; and

(ii) The outer carton and any accom-panying printed matter bear appro-priate, complete cautionary labeling.

(36) Individual toy rocket propellant devices and separate delay train and/or


496

16 CFR Ch. II (1–1–10 Edition) § 1500.83

recovery system activation devices in-tended for use with premanufactured model rocket engines are exempt from bearing the full labeling required by section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such require-ments would be necessary because the articles are flammable or generate pressure, provided that:

(i) The devices are designed and con-structed in accordance with the speci-fications in § 1500.85(a)(8), (9) or (14);

(ii) Each individual device or retail package of devices bears the following:

(A) The statement ‘‘WARNING— FLAMMABLE: Read instructions be-fore use’’;

(B) The common or usual name of the article;

(C) A statement of the type of engine and use classification;

(D) Instructions for safe disposal; and (E) Name and place of business of

manufacturer or distributor; and (iii) Each individual rocket engine or

retail package of rocket engines dis-tributed to users is accompanied by an instruction sheet bearing complete cautionary labeling and instructions for safe use and handling of the indi-vidual rocket engines.

(37) Glues with a cyanoacrylate base in packages containing 3 grams or less are exempt from the requirement of § 1500.121(d) that labeling which is per-mitted to appear elsewhere than on the main label panel must be in type size no smaller than 6 point type, provided that:

(i) The main panel of the immediate container bears both the proper signal word and a statement of the principal hazard or hazards associated with this product, as provided by § 1500.121 (a) and (c);

(ii) The main panel of the immediate container also bears an instruction to read carefully additional warnings elsewhere on the label and on any outer package, accompanying leaflet, and display card. The instruction to read additional warnings must comply with the size, placement, conspicuous-ness, and contrast requirements of § 1500.121; and

(iii) The remainder of the cautionary labeling required by the act that is not on the main label panel must appear elsewhere on the label in legible type

and must appear on any outer package, accompanying leaflet, and display card. If there is no outer package, ac-companying leaflet, or display card, then the remainder of the required cau-tionary labeling must be displayed on a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout the conditions of merchan-dising and distribution to the ultimate consumer. That labeling which must appear on any outer package, accom-panying leaflet, tag, or other suitable material must comply with the size, placement, contrast, and conspicuous-ness requirements of § 1500.121(d).

(38) Rigid or semi-rigid writing in-struments and ink cartridges having a writing point and an ink reservoir are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i) of the regulations) and of regulations issued under section 3(b) of the act (§ 1500.14(b)(1, 2)) insofar as such requirements would be necessary because the ink contained therein is a ‘‘toxic’’ substance as defined in § 1500.3(c)(2)(i) and/or because the ink contains 10 percent or more by weight ethylene glycol or diethylene glycol, if all the following conditions are met:

(i) The writing instrument or car-tridge is of such construction that the ink will, under any reasonably foresee-able condition of manipulation and use, emerge only from the writing tip.

(ii) When tested by the method de-scribed in § 1500.3(c)(2)(i), the ink does not have an LD–50 single oral dose of less than 2.5 grams per kilogram of body weight of the test animal.

(iii) If the ink contains ethylene gly-col or diethylene glycol, the amount of such substance, either singly or in combination, does not exceed 1 gram per writing instrument or cartridge.

(iv) The amount of ink in the writing instrument or cartridge does not ex-ceed 3 grams.

[38 FR 27012, Sept. 27, 1973; 42 FR 33026, June 29, 1977, as amended at 43 FR 32745, July 28, 1978; 43 FR 47176, Oct. 13, 1978; 44 FR 42678, July 20, 1979; 46 FR 11513, Feb. 9, 1981; 48 FR 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, 2003; 74 FR 27249, June 9, 2009]


497


§ 1500.85 Exemptions from classifica-tion as banned hazardous sub-stances.

(a) The term banned hazardous sub-stances as used in section 2(q)(1)(A) of the act shall not apply to the following articles provided that these articles bear labeling giving adequate direc-tions and warnings for safe use:

(1) Chemistry sets and other science education sets intended primarily for juveniles, and replacement components for such sets, when labeled in accord-ance with § 1500.83(a)(23).

(2) Firecrackers designed to produce audible effects, if the audible effect is produced by a charge of not more than 50 milligrams (.772 grains) of pyro-technic composition. (See also § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); and part 1507).

(3) [Reserved] (4) Educational materials such as art

materials, preserved biological speci-mens, laboratory chemicals, and other articles intended and used for edu-cational purposes.

(5) Liquid fuels containing more than 4 percent by weight of methyl alcohol that are intended and used for oper-ation of miniature engines for model airplanes, boats, cars, etc.

(6) Novelties consisting of a mixture of polyvinyl acetate, U.S. Certified Col-ors, and not more than 25 percent by weight of acetone, and intended for blowing plastic balloons.

(7) Games containing, as the sole haz-ardous component, a self-pressurized container of soap solution or similar foam-generating mixture provided that the foam-generating component has no hazards other than being in a self-pres-surized container.

(8) Model rocket propellant devices designed for use in light-weight, recov-erable, and reflyable model rockets, provided such devices:

(i) Are designed to be ignited by elec-trical means.

(ii) Contain no more than 62.5 grams (2.2 ounces) of propellant material and produce less than 80 newton-seconds (17.92 pound seconds) of total impulse with thrust duration not less than 0.050 second.

(iii) Are constructed such that all the chemical ingredients are preloaded into a cylindrical paper or similarly

constructed nonmetallic tube that will not fragment into sharp, hard pieces.

(iv) Are designed so that they will not burst under normal conditions of use, are incapable of spontaneous igni-tion, and do not contain any type of ex-plosive or pyrotechnic warhead other than a small parachute or recovery- system activation charge.

(9) Separate delay train and/or recov-ery system activation devices intended for use with premanufactured model rocket engines wherein all of the chem-ical ingredients are preloaded so the user does not handle any chemical in-gredient and are so designed that the main casing or container does not rup-ture during operation.

(10) Solid fuel pellets intended for use in miniature jet engines for propelling model jet airplanes, speed boats, racing cars, and similar models, provided such solid fuel pellets:

(i) Weigh not more than 11.5 grams each.

(ii) Are coated with a protective res-inous film.

(iii) Contain not more than 35 per-cent potassium dichromate.

(iv) Produce a maximum thrust of not more than 71⁄2 ounces when used as directed.

(v) Burn not longer than 12 seconds each when used as directed.

(11) Fuses intended for igniting fuel pellets exempt under subparagraph (10) of this paragraph.

(12) Kits intended for construction of model rockets and jet propelled model airplanes requiring the use of difluorodichloromethane as a propel-lant, provided the outer carton bears on the main panel in conspicuous type size the statement ‘‘WARNING—Care-fully read instructions and cautions be-fore use.’’

(13) Flammable wire materials in-tended for electro-mechanical actu-ation and release devices for model kits described in paragraph (12) of this section, provided each wire does not ex-ceed 15 milligrams in weight.

(14) Model rocket propellant devices (model rocket motors) designed to pro-pel rocket-powered model cars, pro-vided—

(i) Such devices:


498

16 CFR Ch. II (1–1–10 Edition) § 1500.86

(A) Are designed to be ignited elec-trically and are intended to be oper-ated from a minimum distance of 15 feet (4.6 m) away;

(B) Contain no more than 4 g. of pro-pellant material and produce no more than 2.5 Newton-seconds of total im-pulse with a thrust duration not less than 0.050 seconds;

(C) Are constructed such that all the chemical ingredients are pre-loaded into a cylindrical paper or similarly constructed non-metallic tube that will not fragment into sharp, hard pieces;

(D) Are designed so that they will not burst under normal conditions of use, are incapable of spontaneous ignition, and do not contain any type of explo-sive or pyrotechnic warhead other than a small recovery system activation charge;

(E) Bear labeling, including labeling that the devices are intended for use by persons age 12 and older, and include instructions providing adequate warn-ings and instructions for safe use; and

(F) Comply with the requirements of 16 CFR 1500.83(a)(36)(ii and iii); and

(ii) The surface vehicles intended for use with such devices:

(A) Are lightweight, weighing no more than 3.0 oz. (85 grams), and con-structed mainly of materials such as balsa wood or plastics that will not fragment into sharp, hard pieces;

(B) Are designed to utilize a braking system such as a parachute or shock absorbing stopping mechanism;

(C) Are designed so that they cannot accept propellant devices measuring larger than 0.5″ (13 mm) in diameter and 1.75″ (44 mm) in length;

(D) Are designed so that the engine mount is permanently attached by the manufacturer to a track or track line that controls the vehicle’s direction for the duration of its movement;

(E) Are not designed to carry any type of explosive or pyrotechnic mate-rial other than the model rocket motor used for primary propulsion;

(F) Bear labeling and include instruc-tions providing adequate warnings and instructions for safe use; and

(G) Are designed to operate on a track or line that controls the vehicles’ direction for the duration of their movement and either cannot operate off the track or line or, if operated off

the track or line, are unstable and fail to operate in a guided fashion so that they will not strike the operator or by-standers.

(b) [Reserved]

[38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22935, June 8, 1976; 42 FR 43391, Aug. 29, 1977; 48 FR 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, 2003]

§ 1500.86 Exemptions from classifica-tion as a banned toy or other banned article for use by children.

(a) The term banned hazardous sub-stance as used in section 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)) of the act shall not apply to the fol-lowing articles:

(1) Toy rattles described in § 1500.18(a)(1) in which the rigid wires, sharp protrusions, or loose small ob-jects are internal and provided that such rattles are constructed so that they will not break or deform to expose or release the contents either in nor-mal use or when subjected to reason-ably foreseeable damage or abuse.

(2) Dolls and stuffed animals and other similar toys described in § 1500.18(a)(3) in which the components that have the potential for causing lac-eration, puncture wound injury, or other similar injury are internal, pro-vided such dolls, stuffed animals, and other similar toys are constructed so that they will not break or deform to expose such components either in nor-mal use or when subjected to reason-ably foreseeable damage or abuse.

(3) [Reserved] (4) Any article known as a ‘‘baby-

bouncer,’’ ‘‘walker-jumper,’’ or ‘‘baby- walker’’ and any other similar article (referred to in this paragraph as ‘‘arti-cle(s)’’) described in § 1500.18(a)(6) pro-vided:

(i) The frames are designed and con-structed in a manner to prevent injury from any scissoring, shearing, or pinch-ing when the members of the frame or other components rotate about a com-mon axis or fastening point or other-wise move relative to one another; and

(ii) Any coil springs which expand when the article is subjected to a force that will extend the spring to its max-imum distance so that a space between successive coils is greater than one- eighth inch (0.125 inch) are covered or


499


otherwise designed to prevent injuries; and

(iii) All holes larger than one-eighth inch (0.125 inch) in diameter and slots, cracks, or hinged components in any portion of the article through which a child could insert, in whole or in part a finger, toe, or any other part of the anatomy are guarded or otherwise de-signed to prevent injuries; and

(iv) The articles are designed and constructed to prevent accidental col-lapse while in use; and

(v) The articles are designed and con-structed in a manner that eliminates from any portion of the article the pos-sibility of presenting a mechanical haz-ard through pinching, bruising, lacer-ating, crushing, breaking, amputating, or otherwise injuring portions of the human body when in normal use or when subjected to reasonably foresee-able damage or abuse; and

(vi) Any article which is introduced into interstate commerce after the ef-fective date of this subparagraph is la-beled:

(A) With a conspicuous statement of the name and address of the manufac-turer, packer, distributor, or seller; and

(B) With a code mark on the article itself and on the package containing the article or on the shipping con-tainer, in addition to the invoice(s) or shipping document(s), which code mark will permit future identification by the manufacturer of any given model (the manufacturer shall change the model number whenever the article undergoes a significant structural or design modi-fication); and

(vii) The manufacturer or importer of the article shall make, keep, and main-tain for 3 years records of sale, dis-tribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available at all reasonable hours upon request by any officer or employee of the Consumer Product Safety Commission and shall permit such officer or employee to inspect and copy such records, to make such stock inventories as he deems necessary, and to otherwise check the correctness of such records.

(5) Clacker balls described in § 1500.18(a)(7) that have been designed,

manufactured, assembled, labeled, and tested in accordance with the following requirements, and when tested at the point of production or while in inter-state commerce or while held for sale after shipment in interstate commerce do not exceed the failure rate require-ments of the table in paragraph (a)(5)(vi) of this section:

(i) The toy shall be so designed and fabricated that:

(A) Each ball: Weighs less than 50 grams; will not shatter, crack, or chip; is free of cracks, flash (ridges due to imperfect molding), and crazing (tiny surface cracks); and is free of rough or sharp edges around any hole where the cord enters or over any surface with which the cord may make contact. Each ball is free of internal voids (holes, cavities, or air bubbles) if the balls are made of materials other than those materials (such as ABS (acrylo-nitrile butadiene styrene), nylon, and high-impact polystyrene) that are in-jection-molded and possess high-im-pact characteristics.

(B) The cord: Is of high tensile strength, synthetic fibers that are braided or woven, having a breaking strength in excess of 445 Newtons (100 pounds); is free of fraying or any other defect that might tend to reduce its strength in use; is not molded in balls made of casting resins which tend to wick up or run up on the outside of the cord; and is affixed to a ball at the cen-ter of the horizontal plane of the ball when it is suspended by the cord. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have a minimum cord breaking strength of less than 445 Newtons (100 pounds), as computed by the following formula:

Adjusted Cord Breaking Strength in Newtons=0.1382(mb) (Rp), where mb=mass of a single ball in grams and

Rp=pivot length in mm. (C) When the cord is attached to the

ball by means of a knot, the end be-neath the knot is chemically fused or otherwise treated to prevent the knot from slipping out or untying in use.

(ii) The toy shall be tested at the time of production:

(A) By using the sampling procedure described in the table in subdivision


500

16 CFR Ch. II (1–1–10 Edition) § 1500.86

(vi) of this subparagraph to determine the number of units to be tested.

(B) By subjecting each ball tested to 10 drops of a 2.25 kg (5-pound) steel im-pact rod or weight (57-mm (21⁄4-inch) di-ameter with a flat head) dropped 1220 mm (48 inches) in a vented steel or alu-minum tube (60-mm (23⁄8-inch) inside diameter) when the ball is placed on a steel or cast iron mount. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance be-tween the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may be tested by drop-ping the impact weight from a height of less than 1220 mm (48 in.), where the height is computed as follows:

Adjusted drop height in mm=179×10¥5(mb) (Rp2), where mb=mass of a single ball in grams and

Rp=pivot length in mm.

Any ball showing any chipping, crack-ing, or shattering shall be counted as a failure within the meaning of the third column of the table in paragraph (a)(5)(vi) of this section.

(C) By inspecting each ball tested for smoothness of finish on any surface of the ball which may come in contact with the cord during use. A cotton swab shall be rubbed vigorously over each such surface or area of the ball; if any cotton fibers are removed, the ball shall be counted as a failure within the meaning of the fourth column of the table in subdivision (vi) of this para-graph. The toy shall also be checked to ascertain that there is no visibly per-ceptible ‘‘wicking up’’ or ‘‘running up’’ of the casting resins on the outside of the cord in the vicinity where the ball is attached.

(D) By fully assembling the toy and testing the cord in such a manner as to test both the strength of the cord and the adequacy with which the cord is at-tached to the ball and any holding de-vice such as a tab or ring included in the assembly. The fully assembled arti-cle shall be vertically suspended by one ball and a 445-Newton (100-pound) test applied to the bottom ball. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the dis-tance between the center of the pivot and the center of the ball cannot ex-ceed 180 mm (7.1 inches) may be tested with a force of under 445 Newtons (100

pounds). The test force for these clack-er balls shall be the same as the cord breaking strength calculated in § 1500.86(a)(5)(i)(B). Any breaking, fray-ing, or unraveling of the cord or any sign of slipping, loosening, or unfas-tening shall be counted as a failure within the meaning of the fourth col-umn of the table in paragraph (a)(5)(vi) of this section.

(E) By additionally subjecting any ring or other holding device to a 222- Newton (50-pound) test load applied to both cords; the holding device is to be securely fixed horizontally in a suit-able clamp in such a manner as to sup-port 50 percent of the area of such hold-ing device and the balls are suspended freely. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have their holding device tested with a force of less than 222 Newtons (50 pounds). The holding device test force for these clacker balls shall be half of the cord breaking strength calculated in § 1500.86(a)(5)(i)(B). Any breaking, cracking, or crazing of the ring or other holding device shall be counted as a failure within the meaning of the fourth column of the table in para-graph (a)(5)(vi) of this section.

(F) By cutting each ball tested in half and then cutting each half per-pendicularly to the first cut into three or more pieces of approximately equal thickness. Each portion is to be in-spected before and after cutting, and any ball showing any flash, crack, craz-ing, or internal voids on such inspec-tion is to be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section. Balls that are injection-mold-ed and possess high-impact characteris-tics (such as injection-molded balls made of ABS, nylon, or high-impact polystyrene) though exempt from the requirements that there be no internal voids, must be tested to determine the presence of any flash, crack or grazing. A transparent ball shall be subjected to the same requirements except that it may be visually inspected without cut-ting.

(iii) The toy shall be fully assembled for use at time of sale, including the


501


proper attachments of balls, cords, knots, loops, or other holding devices.

(iv) The toy shall be labeled: (A) With a conspicuous statement of

the name and address of the manufac-turer, packer, distributor, or seller.

(B) To bear on the toy itself and/or the package containing the toy and/or the shipping container, in addition to the invoice(s) and shipping docu-ment(s), a code or mark in a form and manner that will permit future identi-fication of any given batch, lot, or shipment by the manufacturer.

(C) To bear a conspicuous warning statement on the main panel of the re-tail container and display carton and on any accompanying literature: That if cracks develop in a ball or if the cord becomes frayed or loose or unfastened, use of the toy should be discontinued; and if a ring or loop or other holding device is present, the statement ‘‘In use, the ring or loop must be placed around the middle finger and the two cords positioned over the forefinger and held securely between the thumb and forefinger,’’ or words to that effect

which will provide adequate instruc-tions and warnings to prevent the hold-ing device from accidentally slipping out of the hand. Such statements shall be printed in sharply contrasting color within a borderline and in letters at least 6 mm (1⁄4 inch) high on the main panel of the container and at least 3 mm (1⁄8) high on all accompanying lit-erature.

(v) The manufacturer of the toy shall make, keep, and maintain for 3 years records of sale, distribution, and re-sults of inspections and tests con-ducted in accordance with this sub-paragraph and shall make such records available upon request at all reason-able hours by any officer or employee of the Consumer Product Safety Com-mission, and shall permit such officer or employee to inspect and copy such records and to make such inventories of stock as he deems necessary and otherwise to check the correctness of such records.

(vi) The lot size, sample size, and failure rate for testing clacker balls are as follows:

Number of units in batch, shipment, deliv-ery, lot, or retail stock

Number of units in ran-dom sample

Failure rate constituting rejection when testing per

§ 1500.86(a)(5)(ii)(B)

Failure rate constituting rejection when testing per

§ 1500.86(a)(5)(ii) (C), (D), (E), and (F)

50 or less ..................................................... 8 1 1 51 to 90 ....................................................... 13 1 1 91 to 150 ..................................................... 20 1 1 151 to 280 ................................................... 32 1 2 281 to 500 ................................................... 50 1 2 501 to 1,200 ................................................ 80 2 4 1,201 to 3,200 ............................................. 125 2 6 3,201 to 10,000 ........................................... 200 3 10 10,001 to 35,000 ......................................... 315 4 16 35,001 to 150,000 ....................................... 500 6 25 150,001 to 500,000 ..................................... 800 8 40 500,001 and over ........................................ 1,250 11 62

(vii) Applicability of the exemption provided by this paragraph shall be de-termined through use of the table in paragraph (a)(5)(vi) of this section. A random sample of the number of arti-cles as specified in the second column of the table shall be selected according to the number of articles in a par-ticular batch, shipment, delivery, lot, or retail stock per the first column. A failure rate as shown in either the third or fourth column shall indicate that the entire batch, shipment, deliv-ery, lot, or retail stock has failed and thus is not exempted under this para-

graph from classification as a banned hazardous substance.

(6) Caps (paper or plastic) described in § 1500.18(a)(5), provided:

(i) Such articles do not produce peak sound pressure levels greater than 158 decibels when tested in accordance with § 1500.47, and provided any such ar-ticles producing peak sound pressure levels greater than 138 decibels but not greater than 158 decibels when tested in accordance with § 1500.47 shall bear the following statement on the carton and in the accompanying literature in


502

16 CFR Ch. II (1–1–10 Edition) § 1500.86

accordance with § 1500.121: ‘‘WARN-ING—Do not fire closer than 1 foot to the ear. Do not use indoors.’’

(ii) Any person who elects to dis-tribute toy caps in accordance with paragraph (a)(6)(i) of this section shall promptly notify the Consumer Product Safety Commission, Bureau of Compli-ance, Washington, D.C. 20207, of their intention and shall conduct or partici-pate in a program to develop caps that produce a sound pressure level of not more than 138 decibels when tested in accordance with § 1500.47.

(iii) Any person who elects to dis-tribute caps in accordance with para-graph (a)(6)(i) of this section shall, after notification of his intentions to the Commission in accordance with paragraph (a)(6)(ii) of this section, sub-mit to the Consumer Product Safety Commission, Bureau of Compliance, Washington, DC 20207, a progress report not less frequently than once every 3 months concerning the status of his program to develop caps that produce a sound level of not more than 138 deci-bels when tested in accordance with § 1500.47.

(7) Dive sticks and similar articles described in § 1500.18(a)(19) that come to rest at the bottom of a container of water in a position in which the long axis of the article is greater than 45 de-grees from vertical when measured in accordance with the following test method:

(i) Test equipment. (A) A container that is filled with tap

water to a depth at least 3 inches [76 mm] greater than the longest dimen-sion of the dive stick. The container shall:

(1) Be sufficiently wide to allow the dive stick to lie along the bottom with its long axis in a horizontal position,

(2) Have clear side walls to permit ob-servation of the dive stick under water, and

(3) Be placed on a level surface and have a flat bottom.

(B) A protractor or other suitable angle measurement device that has an indicator for 45 degrees from vertical.

(ii) Testing procedure (A) If the dive stick is sold such that

the consumer is required to attach an additional component(s) to the dive stick, then the product shall be tested

both with and without the attach-ment(s).

(B) From just above the water sur-face, drop the dive stick into the con-tainer.

(C) Let the dive stick sink and come to rest at the bottom of the container. If the dive stick is designed so that the weight can be adjusted by adding water or other substance, adjust the weight so that the dive stick sinks and comes to rest with its long axis positioned as close to vertical as possible.

(D) Align the angle measurement de-vice alongside the dive stick under-water and wait for the dive stick to come to rest if there is any water dis-turbance. Determine whether the long axis of the dive stick is greater than or less than 45 degrees from vertical.

(8) Dive sticks and similar articles described in § 1500.18(a)(19) in which the maximum force measured in the fol-lowing test method is less than 5–lbf [22N]. The test shall be conducted in the ambient environment of the labora-tory and not under water.

(i) Test equipment. (A) A compression rig that has a

force gauge or equivalent device that is calibrated for force measurements within a minimum range of 0 to 5 lbf [0–22 N] and with an accuracy of ±0.1 lbf [±0.44 N] or better. The test rig shall have a system to guide this force appli-cation in the vertical direction and shall have a means to adjust the rate of load application.

(B) Compression disk—the loading device that is attached to the force gauge shall be a rigid metal disk with a minimum diameter of 1.125 inches [29 mm].

(C) Vise or other clamping device. (ii) Testing procedure (A) Position the bottom of the dive

stick in the clamping device so that the longest axis of the dive stick is vertical. The bottom end of the dive stick is the end that sinks to the bot-tom of a pool of water. Secure the bot-tom of the dive stick in the clamp such that the clamping mechanism covers no more than the bottom 1⁄2 inch [13 mm] of the dive stick.

(B) Apply a downward force at a rate of 0.05 in/sec (±0.01 in/sec) [1.3 mm.sec ±0.3 mm/sec] at the top of the dive


503


stick with the compression disk posi-tioned so that the plane of the disk contact surface is perpendicular to the long axis of the dive stick.

(C) Apply the load for a period of 40 seconds or until the maximum recorded force exceeds 5-lbf [22 N].

(D) Record the maximum force that was measured during the test.

(b) [Reserved] (9) Boston Billow Nursing Pillow and

substantially similar nursing pillows that are designed to be used only as a nursing aide for breastfeeding mothers. For example, are tubular in form, C- or crescent-shaped to fit around a nursing mother’s waist, round in circumference and filled with granular material.

[38 FR 27012, Sept. 27, 1973, as amended at 53 FR 46839, Nov. 18, 1988; 59 FR 9076, 9077, Feb. 25, 1994; 66 FR 13651, Mar. 7, 2001; 68 FR 70140, Dec. 17, 2003; 73 FR 77495, Dec. 19, 2008]

§ 1500.87 Children’s products con-taining lead: inaccessible compo-nent parts.

(a) The Consumer Product Safety Im-provement Act (CPSIA) provides for specific lead limits in children’s prod-ucts. Section 101(a) of the CPSIA pro-vides that by February 10, 2009, prod-ucts designed or intended primarily for children 12 and younger may not con-tain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm after three years, unless the Com-mission determines that it is not tech-nologically feasible to have this lower limit.

(b) Section 101 (b)(2) of the CPSIA provides that the lead limits do not apply to component parts of a product that are not accessible to a child. This section specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become phys-ically exposed through reasonably fore-seeable use and abuse of the product in-cluding swallowing, mouthing, break-ing, or other children’s activities, and the aging of the product, as determined by the Commission. Paint, coatings, or electroplating may not be considered to be a barrier that would render lead

in the substrate to be inaccessible to a child.

(c) Section 101(b)(2)(B) of the CPSIA directs the Commission to promulgate by August 14, 2009, this interpretative rule to provide guidance with respect to what product components or classes of components will be considered to be inaccessible.

(d) The accessibility probes specified for sharp points or edges under the Commissions’ regulations at 16 CFR 1500.48–1500.49 will be used to assess the accessibility of lead-component parts of a children’s product. A lead-con-taining component part would be con-sidered accessible if it can be contacted by any portion of the specified segment of the accessibility probe. A lead-con-taining component part would be con-sidered inaccessible if it cannot be con-tacted by any portion of the specified segment of the accessibility probe.

(e) For products intended for children that are 18 months of age or less, the use and abuse tests set forth under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite test of § 1500.51(c)), will be used to evaluate accessibility of lead-con-taining component parts of a children’s product as a result of normal and rea-sonably foreseeable use and abuse of the product.

(f) For products intended for children that are over 18 months but not over 36 months of age, the use and abuse tests set forth under the Commission’s regu-lations at 16 CFR 1500.50 and 16 CFR 1500.52 (excluding the bite test of § 1500.52(c)), will be used to evaluate ac-cessibility of lead-containing compo-nent parts of a children’s product as a result of normal and reasonably fore-seeable use and abuse of the product.

(g) For products intended for children that are over 36 months but not over 96 months of age, the use and abuse tests set forth under the Commission’s regu-lations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)), will be used to evaluate ac-cessibility of lead-containing compo-nent parts of a children’s product as a result of normal and reasonably fore-seeable use and abuse of the product.

(h) For products intended for chil-dren over 96 months through 12 years of age, the use and abuse tests set forth


504

16 CFR Ch. II (1–1–10 Edition) § 1500.88

under the Commission’s regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (ex-cluding the bite test of § 1500.53(c)) in-tended for children aged 37–96 months will be used to evaluate accessibility of lead-containing component parts of a children’s product as a result of normal and reasonably foreseeable use and abuse of the product.

(i) A children’s product that is or contains a lead-containing part which is enclosed, encased, or covered by fab-ric and passes the appropriate use and abuse tests on such covers, is inacces-sible to a child unless the product or part of the product in one dimension is smaller than 5 centimeters.

(j) The intentional disassembly or de-struction of products by children older than age 8 years by means or knowl-edge not generally available to younger children, including use of tools, will not be considered in evaluating prod-ucts for accessibility of lead-con-taining components.

[74 FR 39540, Aug. 7, 2009]

§ 1500.88 Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices.

(a) The Consumer Product Safety Im-provement Act (CPSIA) provides for specific lead limits in children’s prod-ucts. Section 101(a) of the CPSIA pro-vides that by February 10, 2009, prod-ucts designed or intended primarily for children 12 and younger may not con-tain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm, unless the Commission deter-mines that it is not technologically feasible to have this lower limit. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inacces-sible to a child.

(b) Section 101(b)(4) of the CPSIA pro-vides that if the Commission deter-mines that it is not technologically feasible for certain electronic devices to comply with the lead limits, the Commission must issue requirements by regulation to eliminate or minimize the potential for exposure to and acces-

sibility of lead in such electronic de-vices and establish a compliance sched-ule unless the Commission determines that full compliance is not techno-logically feasible.

(c) Certain lead-containing compo-nent parts in children’s electronic de-vices unable to meet the lead limits set forth in paragraph (a) of this section due to technological infeasibility are granted the exemptions that follow in paragraph (d) of this section, provided that use of lead is necessary for the proper functioning of the component part and it is not technologically fea-sible for the component part to meet the lead content limits set forth in paragraph (a) of this section.

(d) Exemptions for lead as used in certain component parts in children’s electronic devices include:

(1) Lead blended into the glass of cathode ray tubes, electronic compo-nents and fluorescent tubes.

(2) Lead used as an alloying element in steel. The maximum amount of lead shall be less than 0.35% by weight (3500 ppm).

(3) Lead used in the manufacture of aluminum. The maximum amount of lead shall be less than 0.4% by weight (4,000 ppm).

(4) Lead used in copper-based alloys. The maximum amount of lead shall be less than 4% by weight (40,000 ppm).

(5) Lead used in lead-bronze bearing shells and bushings.

(6) Lead used in compliant pin con-nector systems.

(7) Lead used in optical and filter glass.

(8) Lead oxide in plasma display pan-els (PDP) and surface conduction elec-tron emitter displays (SED) used in structural elements; notably in the front and rear glass dielectric layer, the bus electrode, the black stripe, the address electrode, the barrier ribs, the seal frit and frit ring as well as in print pastes.

(9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps.

(e) Components of electronic devices that are removable or replaceable such as battery packs and light bulbs that are inaccessible when the product is as-sembled in functional form or are oth-erwise granted an exemption are not


505


subject to the lead limits in paragraph (a) of this section.

(f) Commission staff is directed to re-evaluate and report to the Commission on the technological feasibility of com-pliance with the lead limits in para-graph (a) of this section for children’s electronic devices, including the tech-nological feasibility of making acces-sible component parts inaccessible, and the status of the exemptions, no less than every five years after publication of a final rule in the FEDERAL REGISTER on children’s electronic devices.

[74 FR 6993, Feb. 12, 2009]

§ 1500.89 Procedures and require-ments for determinations regarding lead content of materials or prod-ucts under section 101(a) of the Consumer Product Safety Improve-ment Act.

(a) The Consumer Product Safety Im-provement Act provides for specific lead limits in children’s products. Sec-tion 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 years of age or younger may not con-tain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 years of age or younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit will be further re-duced to 100 ppm, unless the Commis-sion determines that this lower limit is not technologically feasible. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inacces-sible to a child or prevent the absorp-tion of any lead in the human body through normal and reasonably fore-seeable use and abuse of the product.

(b) The Commission may, either on its own initiative or upon the request of any interested person, make a deter-mination that a material or product does not contain leads levels that ex-ceed 600 ppm, 300 ppm, or 100 ppm, as applicable.

(c) A determination by the Commis-sion under paragraph (b) of this section that a material or product does not contain lead levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable does not relieve the material or prod-uct from complying with the applicable

lead limit as provided under paragraph (a) of this section.

(d) To request a determination under paragraph (b) of this section, the re-quest must:

(1) Be e-mailed to [email protected]. and ti-tled ‘‘Section 101 Request for Lead Content Determination.’’ Requests may also be mailed, preferably in five copies, to the Of-fice of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, Maryland 20814, or delivered to the same address.

(2) Be written in the English language. (3) Contain the name and address, and e-

mail address or telephone number, of the re-questor.

(4) Provide documentation including: (i) A detailed description of the product or

material and how it is used by a child; (ii) Representative data on the lead con-

tent of parts of the product or materials used in the production of a product;

(iii) All relevant data or information on manufacturing processes through which lead may be introduced into the material or prod-uct;

(iv) An assessment of the likelihood or lack thereof that the manufacturing proc-esses will result in lead contamination of a material or product that ordinarily does not contain lead;

(v) All relevant data or information on the facilities used to manufacture the material or product, and any other materials used in the product;

(vi) An assessment of the likelihood or lack thereof that the use of leaded materials in a facility will result in lead contamina-tion of a material or product that ordinarily does not contain lead;

(vii) Any other information relevant to the potential for lead content of the product or material to exceed the statutory lead limit specified in the request, that is 600 ppm, 300 ppm, or 100 ppm, as applicable;

(viii) Detailed information on the relied upon test methods for measuring lead con-tent of products or materials including the type of equipment used or any other tech-niques employed and a statement as to why the data is representative of the lead content of such products or materials generally; and

(ix) Any data or information that is unfa-vorable to the request that is reasonably available to the requestor.

(e) Where a submission fails to meet all of the requirements of paragraph (d) of this section, the Office of the Sec-retary shall notify the person submit-ting it, describe the deficiency, and ex-plain that the request may be resub-mitted when the deficiency is cor-rected.


506

16 CFR Ch. II (1–1–10 Edition) § 1500.90

(f) Upon receipt of a complete request for a determination, the Office of Haz-ard Identification and Reduction (EXHR) will assess the request to de-termine whether the product or mate-rial is one that does not contain lead in excess of the limits as provided under paragraph (a) of this section. EXHR will make an initial recommendation within thirty (30) calendar days, to the extent practicable. EXHR may request an extension from the Executive Direc-tor of the CPSC, if necessary, to make its initial determination. A complete request is one that does not require ad-ditional information from the re-questor for EXHR to make an initial recommendation to the Commission.

(g) Where the Office of Hazard Identi-fication and Reduction’s (EXHR) ini-tial recommendation is to deny the re-quest for a lead content determination, it will provide, in a staff memorandum to the Commission, submitted to the Commission for ballot vote, the basis for the denial with sufficient detail for the Commission to make an informed decision that reasonable grounds for a determination are not presented. The Commission, by ballot vote, will render a decision on the staff’s recommenda-tion. The ballot vote and the staff memorandum will be posted on the CPSC Web site. Any determination by the Commission to grant a request will be published in the FEDERAL REGISTER for comment. If the Commission con-cludes that the request shall be denied, the requestor shall be notified in writ-ing of the denial from the Office of the Secretary along with the official ballot results and the EXHR staff’s memo-randum of recommendation.

(h) Where the Office of Hazard Identi-fication and Reduction’s (EXHR) ini-tial recommendation is to grant the re-quest for a lead content determination, it will submit the basis for that rec-ommendation to the Commission in a memorandum to be voted on by ballot, with sufficient detail for the Commis-sion to make an informed decision that reasonable grounds for a determination are presented. If the notice of proposed rulemaking (NPR) is published, it will invite public comment in the FEDERAL REGISTER. EXHR will review and evalu-ate any comments and supporting doc-umentation before making its final

recommendation to the Commission for final agency action, by staff memo-randum submitted to the Commission. If the Commission, after review of the staff’s final recommendation, deter-mines that a material or product does not and would not exceed the lead con-tent limits, it will decide by ballot vote, on whether to publish a final rule in the FEDERAL REGISTER.

(i) The filing of a request for a deter-mination does not have the effect of staying the effect of any provision or limit under the statutes and regula-tions enforced by the Commission. Even though a request for a determina-tion has been filed, unless a Commis-sion determination is issued in final form after notice and comment, mate-rials or products subject to the lead limits under section 101 of the CPSIA must be tested in accordance with sec-tion 102 of the CPSIA, unless the test-ing requirement is otherwise stayed by the Commission.

[74 FR 10480, Mar. 11, 2009]

§ 1500.90 Procedures and require-ments for exclusions from lead lim-its under section 101(b) of the Con-sumer Product Safety Improvement Act.

(a) The Consumer Product Safety Im-provement Act provides for specific lead limits in children’s products. Sec-tion 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 years of age or younger may not con-tain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 years of age or younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit will be further re-duced to 100 ppm, unless the Commis-sion determines that this lower limit is not technologically feasible. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inacces-sible to a child or prevent the absorp-tion of any lead in the human body through normal and reasonably fore-seeable use and abuse of the product.

(b) Section 101(b)(1) of the CPSIA pro-vides that the Commission may ex-clude a specific product or material from the lead limits established for


507


children’s products under the CPSIA if the Commission, after notice and a hearing, determines on the basis of the best-available, objective, peer-re-viewed, scientific evidence that lead in such product or material will neither:

(1) Result in the absorption of any lead into the human body, taking into account normal and reasonably fore-seeable use and abuse of such product by a child, including swallowing, mouthing, breaking, or other children’s activities, and the aging of the prod-uct; nor

(2) Have any other adverse impact on public health or safety.

(c) To request an exclusion from the lead limits as provided under para-graph (a) of this section, the request must:

(1) Be e-mailed to [email protected]. and ti-tled ‘‘Section 101 Request for Exclusion of a Material or Product.’’ Requests may also be mailed, preferably in five copies, to the Of-fice of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, Maryland 20814, or delivered to the same address.

(2) Be written in the English language. (3) Contain the name and address, and e-

mail address or telephone number, of the re-questor.

(4) Provide documentation including: (i) A detailed description of the product or

material and how it is used by a child; (ii) Representative data on the lead con-

tent of parts of the product or materials used in the production of a product;

(iii) All relevant data or information on manufacturing processes through which lead may be introduced into the product or mate-rial;

(iv) Any other information relevant to the potential for lead content of the product or material to exceed the CPSIA lead limits that is reasonably available to the requestor;

(v) Detailed information on the relied upon test methods for measuring lead content of products or materials including the type of equipment used or any other techniques em-ployed and a statement as to why the data is representative of the lead content of such products or materials generally; and

(vi) An assessment of the manufacturing processes which strongly supports a conclu-sion that they would not be a source of lead contamination of the product or material, if relevant.

(5) Provide best-available, objective, peer- reviewed, scientific evidence to support a re-quest for an exclusion demonstrating that the normal and reasonably foreseeable use and abuse activity by a child (including swallowing, mouthing, breaking, or other

children’s activities) and the aging of the material or product for which exclusion is sought, will not result in the absorption of any lead into the human body, nor have any other adverse impact on public health or safety. This literature should support a re-quest for exclusion that addresses how much lead is present in the product, how much lead comes out of the product, and the condi-tions under which that may happen and in-formation relating to a child’s interaction, if any, with the product.

(6) Provide best-available, objective, peer- reviewed, scientific evidence that is unfavor-able to the request that is reasonably avail-able to the requestor.

(d) Where a submission fails to meet all of the requirements of paragraph (c) of this section, the Office of the Sec-retary shall notify the person submit-ting it, describe the deficiency, and ex-plain that the request may be resub-mitted when the deficiency is cor-rected.

(e) Upon receipt of a complete re-quest for an exclusion, the Office of Hazard Identification and Reduction (EXHR) will assess the request to de-termine whether, on the basis of its re-view of the submitted materials, that the normal and reasonably foreseeable use and abuse activity by a child (in-cluding swallowing, mouthing, break-ing, or other children’s activities) and the aging of the material or product for which exclusion is sought, will not re-sult in the absorption of any lead into the human body nor have any other ad-verse impact on health or safety. EXHR will make an initial rec-ommendation within thirty (30) cal-endar days to the extent practicable. EXHR may request an extension from the Executive Director of the CPSC, if necessary, to make its initial rec-ommendation. A complete request is one that does not require additional in-formation from the requestor for EXHR to make an initial recommenda-tion to the Commission.

(f) Where the Office of Hazard Identi-fication and Reduction’s (EXHR) ini-tial recommendation is to deny the re-quest for an exclusion, it will provide in a staff memorandum to the Commis-sion, submitted to the Commission for ballot vote, the basis for denial with sufficient detail for the Commission to make an informed decision that rea-sonable grounds for an exclusion are


508

16 CFR Ch. II (1–1–10 Edition) § 1500.91

not presented. The Commission, by bal-lot vote, will render a decision on the staff’s recommendation. The ballot vote and the staff memorandum will be posted on the CPSC Web site. Any de-termination by the Commission to grant a request will be published in the FEDERAL REGISTER for comment. If the Commission concludes that the request shall be denied, the requestor shall be notified in writing of the denial from the Office of the Secretary along with the official ballot results and the EXHR’s staff’s memorandum of rec-ommendation.

(g) Where the Office of Hazard Identi-fication and Reduction’s (EXHR) ini-tial recommendation is to grant the ex-clusion, it will submit the basis for that recommendation to the Commis-sion in a memorandum to be voted on by ballot, with sufficient detail for the Commission to make an informed deci-sion that reasonable grounds for a de-termination are presented. If the no-tice of proposed rulemaking (NPR) is published, it will invite public com-ment in the FEDERAL REGISTER. EXHR will review and evaluate the comments and supporting documentation before making its final recommendation to the Commission, by staff memorandum submitted to the Commission, for final agency action. If the Commission, after review of the staff’s final recommenda-tion, determines that an exclusion is supported by the evidence, it will de-cide by ballot vote, on whether to pub-lish a final rule in the FEDERAL REG-ISTER.

(h) The filing of a request for exclu-sion does not have the effect of staying the effect of any provision or limit under the statutes and regulations en-forced by the Commission. Even though a request for an exclusion has been filed, unless an exclusion is issued in final form by the Commission after notice and comment, materials or products subject to the lead limits under section 101 of the CPSIA are con-sidered to be banned hazardous sub-stances if they do not meet the lead limits as provided under paragraph (a) of this section.

[74 FR 10480, Mar. 11, 2009]

§ 1500.91 Determinations regarding lead content for certain materials or products under section 101 of the Consumer Product Safety Improve-ment Act.

(a) The Consumer Product Safety Im-provement Act provides for specific lead limits in children’s products. Sec-tion 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended pri-marily for children 12 and younger can-not contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm, unless the Commission determines that it is not technologically feasible to have this lower limit. Paint, coatings or electro-plating may not be considered a barrier that would make the lead content of a product inaccessible to a child. Mate-rials used in products intended pri-marily for children 12 and younger that are treated or coated with paint or similar surface-coating materials that are subject to 16 CFR part 1303, must comply with the requirements for lead paint under section 14(a) of the Con-sumer Product Safety Act (CPSA), as amended by section 102(a) of the CPSIA.

(b) Section 3 of the CPSIA grants the Commission general rulemaking au-thority to issue regulations, as nec-essary, either on its own initiative or upon the request of any interested per-son, to make a determination that a material or product does not exceed the lead limits as provided under para-graph (a) of this section.

(c) A determination by the Commis-sion under paragraph (b) of this section that a material or product does not contain lead levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable, does not relieve the material or prod-uct from complying with the applicable lead limit as provided under paragraph (a) of this section if the product or ma-terial is changed or altered so that it exceeds the lead content limits.

(d) The following materials do not ex-ceed the lead content limits under sec-tion 101(a) of the CPSIA provided that these materials have neither been


509


treated or adulterated with the addi-tion of materials that could result in the addition of lead into the product or material:

(1) Precious gemstones: diamond, ruby, sapphire, emerald.

(2) Semiprecious gemstones and other minerals, provided that the mineral or material is not based on lead or lead compounds and is not associated in na-ture with any mineral based on lead or lead compounds (excluding any mineral that is based on lead or lead com-pounds including, but not limited to, the following: aragonite, bayldonite, boleite, cerussite, crocoite, galena, linarite, mimetite, phosgenite, vanadinite, and wulfenite).

(3) Natural or cultured pearls. (4) Wood. (5) Paper and similar materials made

from wood or other cellulosic fiber, in-cluding, but not limited to, paperboard, linerboard and medium, and coatings on such paper which become part of the substrate.

(6) CMYK process printing inks (ex-cluding spot colors, other inks that are not used in CMYK process, inks that do not become part of the substrate under 16 CFR part 1303, and inks used in after-treatment applications, including screen prints, transfers, decals, or other prints).

(7) Textiles (excluding after-treat-ment applications, including screen prints, transfers, decals, or other prints) consisting of:

(i) Natural fibers (dyed or undyed) in-cluding, but not limited to, cotton, kapok, flax, linen, jute, ramie, hemp, kenaf, bamboo, coir, sisal, silk, wool (sheep), alpaca, llama, goat (mohair, cashmere), rabbit (angora), camel, horse, yak, vicuna, qiviut, guanaco;

(ii) Manufactured fibers (dyed or undyed) including, but not limited to, rayon, azlon, lyocell, acetate, triacetate, rubber, polyester, olefin, nylon, acrylic, modacrylic, aramid, spandex.

(8) Other plant-derived and animal- derived materials including, but not limited to, animal glue, bee’s wax, seeds, nut shells, flowers, bone, sea shell, coral, amber, feathers, fur, leath-er.

(e) The following metals and alloys do not exceed the lead content limits

under section 101(a) of the CPSIA, pro-vided that no lead or lead-containing metal is intentionally added but does not include the non-steel or non-pre-cious metal components of a product, such as solder or base metals in elec-troplate, clad, or fill applications:

(1) Surgical steel and other stainless steel within the designations of Unified Numbering System, UNS S13800–S66286, not including the stainless steel des-ignated as 303Pb (UNS S30360).

(2) Precious metals: Gold (at least 10 karat); sterling silver (at least 925/ 1000); platinum; palladium; rhodium; osmium; iridium; ruthenium, titanium.

[74 FR 43041, Aug. 26, 2009]

§ 1500.121 Labeling requirements; prominence, placement, and con-spicuousness.

(a)(1) Background and scope. Section 2(p)(1) of the Federal Hazardous Sub-stances Act (FHSA) or ‘‘the Act’’), 15 U.S.C. 1261(p)(1), requires that haz-ardous substances bear certain cau-tionary statements on their labels. These statements include: signal words; affirmative statements of the principal hazard(s) associated with a hazardous substance; the common or usual name, or chemical name, of the hazardous substance; the name and place of business of the manufacturer, packer, distributor, or seller; state-ments of precautionary measures to follow; instructions, when appropriate, for special handling and storage; the statement ‘‘Keep Out of the Reach of Children’’ or its practical equivalent; and, when appropriate, first-aid in-structions. Section 2(p)(2) of the Act specifies that all such statements shall be located prominently on the label of such a substance and shall appear in conspicuous and legible type in con-trast by typography, layout, or color with other printed matter on the label. This regulation contains the Commis-sion’s interpretations and policies for the type size and placement of cau-tionary material on the labels of haz-ardous substances and contains other criteria for such cautionary statements that are acceptable to the Commission as satisfying section 2(p)(2) of the Act. Labels that do not comply with this regulation may be considered mis-branded.


510

16 CFR Ch. II (1–1–10 Edition) § 1500.121

(2) Definitions. For the purposes of this section:

(i) Container means the immediate package from which a hazardous sub-stance may be dispensed and also any article, package or wrapping, such as a tube or cone used for a firework or a wet cell battery casing containing sul-furic acid, which is necessary for the substance to function during actual use.

(ii) Cautionary material, cautionary la-beling, and cautionary labeling required by the Act mean all items of labeling information required by sections 2(p)(1) of the FHSA (repeated in 16 CFR 1500.3(b)(14)(i) or by the regulations which require additional labeling under section 3(b) of the Act.

(iii) Display panel means any surface of the immediate container, and of any outer container or wrapping, which bears labeling.

(iv) Principal display panel means the portion(s) of the surface of the imme-diate container, and of any outer con-tainer or wrapping, which bear(s) the labeling designed to be most promi-nently displayed, shown, presented, or examined under conditions of retail sale. (See paragraph (c)(1) of this sec-tion.)

(v) Type size means the actual height of the printed image of each upper case or capital letter as it appears on the label of a hazardous substance. (See paragraph (c)(2) of this section.)

(vi) Signal word means the appro-priate word ‘‘DANGER,’’ ‘‘WARNING,’’ or ‘‘CAUTION,’’ as required by sections 2(p)(1) (C) or (D) of the Act.

(vii) Statement of principal hazard(s) means that wording descriptive of the principal or primary hazard(s) associ-ated with a hazardous substance re-quired by section 2(p)(1)(E) of the Act. Some examples of such statements are ‘‘HARMFUL OR FATAL IF SWAL-LOWED,’’ ‘‘VAPOR HARMFUL,’’ ‘‘FLAMMABLE,’’ and ‘‘SKIN AND EYE IRRITANT.’’

(viii) Other cautionary material means all labeling statements, other than ‘‘signal words’’ or ‘‘statement(s) of principal hazard(s),’’ required by the Act or by regulations issued under the Act.

(b) Prominent label placement. To sat-isfy the requirement of the Act that

cautionary labeling statements shall appear ‘‘prominently’’ on the label of a hazardous substance, all such state-ments shall be placed on the label as follows:

(1) Horizontal placement of labeling statements. Except for the name and place of business of the manufacturer, packer, distributor, or seller, all cau-tionary material required by the Act shall appear in lines that are generally parallel to any base on which the pack-age rests as it is designed to be dis-played for sale or, on display panels other than the principal display panel, in lines generally parallel to all other labeling on that panel. This require-ment does not apply to labeling on col-lapsible tubes, cylindrical containers with a narrow diameter, or F-type con-tainers where both the ‘‘front’’ and ‘‘back’’ of the container are principal display panels. (See paragraph (e) of this section.)

(2) Principal display panel labeling. (i) All items of cautionary labeling re-quired by the Act may appear on the principal display panel on the imme-diate container and, if appropriate, on any other container or wrapper. See paragraph (b)(4) of this section for re-quirements and exceptions for labeling outer containers and wrappings.

(ii) The signal word, the statement of principal hazard(s), and, if appropriate, instructions to read carefully any cau-tionary material that may be placed elsewhere on the label shall be blocked together within a square or rectan-gular area, with or without a border, on the principal display panel on the immediate container and, where re-quired by paragraph (b)(4) of this sec-tion, on any outer container or wrap-ping. All cautionary statements placed on the principal display panel shall be separated on all sides from other print-ed or graphic matter, with the excep-tion of the declaration of net contents required under the Fair Packaging and Labeling Act, 15 U.S.C. 1453(a) (2) and (3), by a border line or by a space no smaller than the minimum allowable height of the type size for cautionary material required by the Act (exclusive of signal words and statements of haz-ard) on the principal display panel.

(iii) Depending on the design of the package or the configuration of the


511


label, or both, a package may have more than one principal display panel. If so, each principal display panel must bear, at a minimum, the signal word, statement of principal hazard or haz-ards, and, if appropriate, instructions to read carefully any cautionary mate-rial that may be placed elsewhere on the label.

(A) Where the principal display panel of the immediate container consists of a lid, cap, or other item which may be separated from the immediate con-tainer and discarded, the container shall be deemed to have a second prin-cipal display panel elsewhere on the immediate container which must bear, at a minimum, the signal word, state-ment of principal hazard(s), and in-structions, if appropriate, to read any cautionary material which may be placed elsewhere on the label.

(3) Prominent label placement—other display panel labeling. All items of cau-tionary labeling required by the Act which do not appear on the principal display panel shall be placed together on a display panel elsewhere on the container. The name and place of busi-ness of the manufacturer, packer, dis-tributor, or seller may appear sepa-rately on any display panel. Where cau-tionary material appears on a display panel other than the principal display panel, the principal display panel shall bear the statement ‘‘Read carefully other cautions on the lll panel,’’ or its practical equivalent. [A description of the location of the other panel is to be inserted in the blank space.]

(4) Outer container or wrappings. All cautionary labeling appearing on the immediate container of a hazardous substance shall also appear on any outer container or wrapping used in the retail display of the substance, in the same manner as required for the immediate container. Those cau-tionary labeling statements appearing on the immediate container which are clearly legible through any outer con-tainer or wrapper used in retail display need not appear on the outer container or wrapping itself. (See section 2(n)(1) of the Act.)

(5) Placement of the word ‘‘Poison’’ and the skull and crossbones symbol. The word ‘‘poison’’ and, when appropriate, the skull and crossbones symbol shall

appear on the label of a hazardous sub-stance as follows:

(i) If a hazardous substance is ‘‘high-ly toxic,’’ as defined in § 1500.3(c)(i) and section 2(h)(1) of the FHSA, the label must bear the word ‘‘poison’’ in accord-ance with section 2(p)(1)(H) of the Act, in addition to the signal word ‘‘DAN-GER,’’ and must also bear the skull and crossbones symbol. Some products, under § 1500.14(b) of the regulations, may, in addition to any required signal word, be required to bear the word ‘‘poison’’ and the skull and crossbones symbol because of the special hazard associated with their ingredients. In both instances, the word ‘‘poison’’ and the skull and crossbones symbol need not appear on the principal display panel on the container, unless all other cautionary labeling required by the Act appears on the principal display panel. The word ‘‘poison’’ and the skull and crossbones symbol, when required, must appear either together with other cautionary labeling on a display panel other than the principal display panel or together with the signal word and statement(s) of principal hazard on the principal display panel.

(ii) Where, pursuant to a regulation issued under section 3(b) of the Act, the label of a hazardous substance requires the word ‘‘poison’’ instead of a signal word, the word, ‘‘POISON’’ shall appear in capital letters on the principal dis-play panel, together with the state-ment(s) of the principal hazard. Certain substances for which the word ‘‘poi-son’’ is required instead of any signal word are listed in § 1500.129.

(c) Conspicuousness—type size and style. To satisfy the requirement that cautionary labeling statements under the Act be conspicuous and legible, such statements shall conform to the following requirements:

(1) Area of principal display panel. The area of the principal display panel is the area of the side or surface of the immediate container, or of the side or surface of any outer container or wrap-ping, that bears the labeling designed to be most prominently displayed, shown, presented, or examined under conditions of retail sale. This area is not limited to the portion of the sur-face covered with labeling; rather, it includes the entire surface. Flanges at


512

16 CFR Ch. II (1–1–10 Edition) § 1500.121

the tops and bottoms of cans, conical shoulders of cans, handles, and shoul-ders and necks of bottles and jars are excluded in measuring the area. For the purposes of determining the proper type size for cautionary labeling, the area of the principal display panel (or other panel bearing cautionary label-ing, under paragraph (c)(2)(ii) of this section) is to be computed as follows:

(i) In the case of a rectangular pack-age, where one entire side is the prin-cipal display panel, the product of the height times the width of that side shall be the area of the principal dis-play panel.

(ii) In the case of a cylindrical or nearly cylindrical container or tube on which the principal display panel ap-pears on the side, the area of the prin-cipal display panel shall be 40 percent of the product of the height of the con-tainer times its circumference.

(iii) In the case of any other shape of container, the area of the principal dis-play panel shall be 40 percent of the total surface of the container, exclud-ing those areas, such as flanges at tops and bottoms, specified in paragraph (c)(1) above. However, if such a con-tainer presents an obvious principal

display panel (such as an oval or hour- glass shaped area on the side of a con-tainer for dishwashing detergent), the area to be measured shall be the entire area of the obvious principal display panel.

(2) Type-size requirements. (i) The term type size refers to the height of the ac-tual printed image of each upper case or capital letter as it appears on the label. The size of cautionary labeling shall be reasonably related to the type size of any other printing appearing on the same panel, but in any case must meet the minimum size requirements in table 1.

(ii) When an item of labeling is re-quired to be in a specified type size, all upper case, or capital, letters must be at least equal in height to the required type size, and all other letters must be the same style as the upper case or capital letters. Unless otherwise speci-fied in the regulations (examples ap-pear at §§ 1500.14(b)(6), 1512.19, 1508.9, and part 1505), the type size of all cau-tionary statements appearing on any display panel shall comply with the specifications in table 1 when the area of the display panel is measured by the method in paragraph (c)(1) above:

TABLE I Area of principal display panel in square inches ........... 0–2 >2–5 >5–10 >10–15 >15–30 >30 Type size in inches * ....................................................... ........ .......... ............ .............. .............. ........

Signal word ** .......................................................... 3⁄64 1⁄16 3⁄32 7⁄64 1⁄8 5⁄32 Statement of hazard ................................................ 3⁄64 3⁄64 1⁄16 3⁄32 3⁄32 7⁄64 Other cautionary material *** ................................... 1⁄32 3⁄64 1⁄16 1⁄16 5⁄64 3⁄32

> means ‘‘greater than.’’ * minimum height of printed image of capital or upper case letters. ** including the word ‘‘poison’’ when required instead of a signal word by Section 3(b) of the Act (§ 1500.129). *** size of lettering for other cautionary material is based on the area of the display panel on which such cautionary material

appears.

(iii) If all of the required cautionary labeling does not appear on the prin-cipal display panel, the statement to ‘‘Read carefully other cautions on the lll panel,’’ or its practical equiva-lent, must appear in, as a minimum, the same type size as that required in table 1 for the other cautionary mate-rial which appears elsewhere on the label of a hazardous substance. The size of the cautionary labeling that does not appear on the principal display panel is determined by the area of the panel on which it does appear.

(3) Type style—proportion. The ratio of the height of a capital or uppercase let-

ter to its width shall be such that the height of the letter is no more than 3 times its width.

(4) Signal word and statements of haz-ard—capital letters. The signal word, the word ‘‘poison’’ if required instead of a signal word (see § 1500.129), and the statement of principal hazard or haz-ards shall be in capital letters.

(5) Multiple statement of hazard—type size and style. All statements of prin-cipal hazard or hazards on a label shall appear in the same size and style of type, and shall appear in the same color or have the same degree of bold-ness.


513


(6) Accompanying literature containing directions for use. Where literature ac-companying the package of a haz-ardous substance has directions for use, written or otherwise, section 2(n) of the Act requires the literature to bear cautionary labeling.

(i) All such cautionary labeling shall be in reasonable proximity to any di-rection for use and shall be placed to-gether within the same general area.

(ii) The type size of such cautionary labeling shall be reasonably related to the type size of any other printed mat-ter in the accompanying literature and must be in conspicuous and legible type by typography, layout, or color with other printed matter on the label. The signal word and statement of prin-cipal hazard or hazards shall appear in capital letters.

(d) Conspicuousness—contrast. To sat-isfy the requirement that cautionary labeling statements appear in con-spicuous and legible type which is in contrast by typography, layout, or color with the other printed matter on the label, such statements shall con-form to the following requirements:

(1) Color. Where color is the primary method used to achieve appropriate contrast, the color of any cautionary labeling statement shall be in sharp contrast with the color of the back-ground upon which such a statement appears. Examples of combinations of colors which may not satisfy the re-quirement for sharp contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan back-ground.

(2) Interference with conspicuousness— labeling design, vignettes, or other printed material. For cautionary information appearing on panels other than the principal display panel, the label de-sign, the use of vignettes, or the prox-imity of other labeling or lettering shall not be such that any cautionary labeling statement is obscured or ren-dered inconspicuous.

(e) Collapsible metal tubes. Collapsible metal tubes containing hazardous sub-stances shall be labeled so that all cau-tionary labeling required by the Act appears as close to the dispensing end

of the container as possible. The place-ment and conspicuousness of these statements shall conform to the provi-sions of paragraphs (b), (c), and (d) of this section.

(f) Unpackaged hazardous substances. Where practicable, unpackaged haz-ardous substances intended, or distrib-uted in a form suitable, for use in or around a household or by children shall be labeled so that all items of informa-tion required by the Act appear upon the article itself. In instances where this is impracticable (for example, be-cause of the size or nature of the arti-cle), the required cautionary labeling must be displayed by means of a tag or other suitable material that is no less than five square inches in area and is securely affixed to the article so that the labeling will remain attached throughout conditions of merchan-dising and distribution to the ultimate consumer. The placement and con-spicuousness of all cautionary labeling appearing on such a tag or material, or on an unpackaged article, shall con-form to the provisions of paragraphs (b), (c), and (d) of this section. For the purposes of determining the proper type size to use on a tag or other mate-rial, the area of one side of the tag or other material shall be the area of the principal display panel.

(g) Exemptions. All requirements of the Act are satisfied by compliance with this § 1500.121. However, exemp-tions can be granted under section 3(c) of the Act and § 1500.83, or under the provisions of another statute should this section be incorporated in regula-tions under another statute. Section 1500.82 contains the requirements for exemption requests under the Federal Hazardous Substances Act.

(h) Effective date. The provisions of this rule apply to hazardous substances bearing labels printed after December 30, 1985. Labels printed prior to the ef-fective date of this rule may be applied until not later than December 28, 1987. This rule applies to all hazardous sub-stances to which labels are applied after December 28, 1987.

[49 FR 50383, Dec. 28, 1984]


514

16 CFR Ch. II (1–1–10 Edition) § 1500.122

§ 1500.122 Deceptive use of dis-claimers.

A hazardous substance shall not be deemed to have met the requirements of section 2(p) (1) and (2) of the act (re-peated in § 1500.3(b)(14) (i) and (ii)) if there appears in or on the label (or in any accompanying literature; words, statements, designs, or other graphic material that in any manner negates or disclaims any of the label state-ments required by the act; for example, the statement ‘‘Harmless’’ or ‘‘Safe around pets’’ on a toxic or irritant sub-stance.

§ 1500.123 Condensation of label infor-mation.

Whenever the statement of the prin-cipal hazard or hazards itself provides the precautionary measures to be fol-lowed or avoided, a clear statement of the principal hazard will satisfy the re-quirements of section 2(p)(1) (E) and (F) of the act (repeated in § 1500.3(b)(14)(i) (E) and (F)). When the statement of precautionary measures in effect provides instruction for first- aid treatment, the statement of the precautionary measures will satisfy the requirements of section 2(p)(1) (F) and (G) of the act (repeated in § 1500.3(b)(14)(i) (F) and (G)).

§ 1500.125 Labeling requirements for accompanying literature.

When any accompanying literature includes or bears any directions for use (by printed word, picture, design, or combination thereof), such placard, pamphlet, booklet, book, sign, or other graphic or visual device shall bear all the information required by section 2(p) of the act (repeated in § 1500.3(b)(14)).

§ 1500.126 Substances determined to be ‘‘special hazards.’’

Whenever the Commission deter-mines that for a particular hazardous substance intended or packaged in a form suitable for use in the household or by children, the requirements of sec-tion 2(p) of the act (repeated in § 1500.3(b)(14)) are not adequate for the protection of the public health and safety because of some special hazard, the Commission, by an appropriate order in the FEDERAL REGISTER, shall

specify such reasonable variations or additional label requirements that it finds are necessary for the protection of the public health and safety. Such order shall specify a date that is not less than 90 days after the order is pub-lished (unless emergency conditions stated in the order specify an earlier date) after which any such hazardous substance intended, or packaged in a form suitable, for use in the household or by children that fails to bear a label in accordance with such order shall be deemed to be a misbranded hazardous substance.

§ 1500.127 Substances with multiple hazards.

(a) Any article that presents more than one type of hazard (for example, if the article is both toxic and flam-mable) must be labeled with: An af-firmative statement of each such haz-ard; the precautionary measures de-scribing the action to be followed or avoided for each such hazard; instruc-tions, when necessary or appropriate, for first-aid treatment of persons suf-fering from the ill effects that may re-sult from each such hazard; instruc-tions for handling and storage of arti-cles that require special care in han-dling and storage because of more than one type of hazard presented by the ar-ticle; and the common or usual name (or the chemical name if there is no common or usual name) for each haz-ardous component present in the arti-cle.

(b) Label information referring to the possibility of one hazard may be com-bined with parallel information con-cerning any additional hazards pre-sented by the article if the resulting condensed statement contains all of the information needed for dealing with each type of hazard presented by the article.

[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973]

§ 1500.128 Label comment. The Commission will offer informal

comment on any proposed label and ac-companying literature involving a haz-ardous substance if furnished with:

(a) Complete labeling or proposed la-beling, which may be in draft form.

(b) Complete quantitative formula.


515


(c) Adequate clinical pharma-cological, toxicological, physical, and chemical data applicable to the pos-sible hazard of the substance.

(d) Any other information available that would facilitate preparation of a suitable label, such as complaints of injuries resulting from the product’s use or other evidence that would fur-nish human-experience data.

§ 1500.129 Substances named in the Federal Caustic Poison Act.

The Commission finds that for those substances covered by the Federal Caustic Poison Act (44 Stat. 1406), the requirements of section 2(p)(1) of the Federal Hazardous Substances Act (re-peated in § 1500.3(b)(14)(i)) are not ade-quate for the protection of the public health. Labeling for those substances, in the concentrations listed in the Fed-eral Caustic Poison Act, were required to bear the signal word ‘‘poison.’’ The Commission concludes that the lack of the designation ‘‘poison’’ would indi-cate to the consumer a lesser hazard and that such would not be in the in-terest of the public health. Under the authority granted in section 3(b) of the act, the Commission therefore finds that for the following substances, and at the following concentrations, the word ‘‘poison’’ is necessary instead of any signal word:

(a) Hydrochloric acid and any prepa-ration containing free or chemically unneutralized hydrochloric acid (HCl) in a concentration of 10 percent or more.

(b) Sulfuric acid and any preparation containing free or chemically unneutralized sulfuric acid (H2 SO4) in a concentration of 10 percent or more.

(c) Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO3) in a concentration of 5 percent or more.

(d) Carbolic acid (C6 H5 OH), also known as phenol, and any preparation containing carbolic acid in a con-centration of 5 percent or more.

(e) Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (H2 C2 O4) in a concentration of 10 percent or more.

(f) Any salt of oxalic acid and any preparation containing any such salt in a concentration of 10 percent or more.

(g) Acetic acid or any preparation containing free or chemically unneutralized acetic acid (HC2 H2 O2) in a concentration of 20 percent or more.

(h) Hypochlorous acid, either free or combined, and any preparation con-taining the same in a concentration that will yield 10 percent or more by weight of available chlorine.

(i) Potassium hydroxide and any preparation containing free or chemi-cally unneutralized potassium hydrox-ide (KOH), including caustic potash and vienna paste (vienna caustic), in a con-centration of 10 percent or more.

(j) Sodium hydroxide and any prepa-ration containing free or chemically unneutralized sodium hydroxide (NaOH), including caustic soda and lye in a concentration of 10 percent or more.

(k) Silver nitrate, sometimes known as lunar caustic, and any preparation containing silver nitrate (AgNO3) in a concentration of 5 percent or more.

(l) Ammonia water and any prepara-tion containing free or chemically uncombined ammonia (NH3), including ammonium hydroxide and ‘‘hartshorn,’’ in a concentration of 5 percent or more.

§ 1500.130 Self-pressurized containers: labeling.

(a) Self-pressurized containers that fail to bear a warning statement ade-quate for the protection of the public health and safety may be misbranded under the act, except as otherwise pro-vided pursuant to section 3 of the act.

(b) The following warning statement will be considered as meeting the re-quirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) if the only hazard associated with an article is that the contents are under pressure:

WARNING—CONTENTS UNDER PRESSURE

Do not puncture or incinerate container. Do not expose to heat or store at tempera-tures above 120 °F. Keep out of the reach of children.

The word ‘‘CAUTION’’ may be sub-stituted for the word ‘‘WARNING’’. A practical equivalent may be sub-stituted for the statement ‘‘Keep out of the reach of children.’’

(c) That portion of the warning state-ment set forth in paragraph (b) of this


516

16 CFR Ch. II (1–1–10 Edition) § 1500.133

section in capital letters should be printed on the main (front) panel of the container in capital letters of the type size specified in § 1500.121(c). The bal-ance of the cautionary statements may appear together on another panel if the front panel also bears a statement such as ‘‘Read carefully other cautions on lllll panel.’’

(d) If an article has additional haz-ards, such as skin or eye irritancy, tox-icity, or flammability, appropriate ad-ditional front and rear panel pre-cautionary labeling is required.

§ 1500.133 Extremely flammable con-tact adhesives; labeling.

(a) Extremely flammable contact ad-hesives, also known as contact bonding cements, when distributed in con-tainers intended or suitable for house-hold use may be misbranded under the act if the containers fail to bear a warning statement adequate for the protection of the public health and safety.

(b) The following warning statement is considered as the minimum cau-tionary labeling adequate to meet the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) with respect to containers of more than one- half pint of contact adhesive and simi-lar liquid or semiliquid articles having a flashpoint at or below 20 °F. as deter-mined by the method in § 1500.43, when the only hazard foreseeable is that caused by the extreme flammability of the mixture:

DANGER

EXTREMELY FLAMMABLE

VAPORS MAY CAUSE FLASH FIRE

Vapors may ignite explosively. Prevent buildup of vapors—open all win-

dows and doors—use only with cross-ventila-tion.

Keep away from heat, sparks, and open flame.

Do not smoke, extinguish all flames and pilot lights, and turn off stoves, heaters, electric motors, and other sources of ignition during use and until all vapors are gone.

Close container after use. Keep out of the reach of children. (c) The words that are in capital let-

ters in the warning statement set forth in paragraph (b) of this section should be printed on the main (front) panel or panels of the container in capital let-

ters of the type size specified in § 1500.121(c). The balance of the cau-tionary information may appear to-gether on another panel provided the front panel bears a statement such as ‘‘Read carefully other cautions on lll panel,’’ the blank being filled in with the identification of the specific label panel bearing the balance of the cautionary labeling. It is recommended that a borderline be used in conjunc-tion with the cautionary labeling.

(d) If an article has additional haz-ards, or contains ingredients listed in § 1500.14 as requiring special labeling, appropriate additional front and rear panel precautionary labeling is re-quired.

(e) Since the Commission has issued a regulation banning under the Con-sumer Product Safety Act extremely flammable contact adhesives covered by this labeling regulation (sec. 16 CFR part 1302), paragraphs (a), (b), (c) and (d) of this section are revoked as to the subject products after June 13, 1978.

[38 FR 27012, Sept. 27, 1973, as amended at 42 FR 63742, Dec. 19, 1977]

§ 1500.134 Policy on first aid labeling for saline emesis.

(a) This section states the Consumer Product Safety Commission’s policy concerning first aid instructions for the use of a salt solution to induce vomiting (saline emesis) in the event of ingestion of hazardous substances.

(b) In many cases where hazardous substances are ingested, the rec-ommended first aid instructions for in-ducing vomiting have contained a statement that this should be accom-plished by drinking a solution of salt (sodium chloride) in warm water. At one time, this direction was considered medically acceptable. However, the Commission has obtained information showing that the instruction to per-form saline emesis is no longer appro-priate. This is because the use of salt to induce vomiting can cause severe hypernatremia (salt poisoning) with potentially toxic effects, particularly in children 5 years old or younger, the age group most often involved in acci-dental poisonings. In view of the avail-ability of safer and more effective


517


emetics such as ipecac syrup, the Com-mission no longer recommends a direc-tion to perform saline emesis as a first aid direction for inducing vomiting.

(c) The Commission believes that, for products for which directions for saline emesis have been given in the past, ipe-cac syrup, U.S.P., is the most appro-priate emetic, unless a particular con-traindication exists in connection with any particular hazardous substance.

(d) The Commission wishes to empha-size that this policy does not require that any specific first aid instruction or wording be used. Where appropriate, the label may include directions (1) that the victim immediately contact a doctor or poison control center and/or (2) that vomiting be induced using methods other than salt. It is, of course, the manufacturer’s responsi-bility to insure that the label provides enough information in addition to first aid instructions to fulfill all other la-beling required by statute or regula-tion.

(Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a)))

[43 FR 33704, Aug. 1, 1978]

§ 1500.135 Summary of guidelines for determining chronic toxicity.

A substance may be toxic due to a risk of a chronic hazard. (A regulatory definition of ‘‘toxic’’ that pertains to chronic toxicity may be found at 16 CFR 1500.3(c)(2).) The following discus-sions are intended to help clarify the complex issues involved in assessing risk from substances that may poten-tially cause chronic hazards and, where possible, to describe conditions under which substances should be considered toxic due to a risk of the specified chronic hazards. The guidelines are not intended to be a static classification system, but should be considered along with available data and with expert judgment. They are not mandatory. Rather, the guidelines are intended as an aid to manufacturers in determining whether a product subject to the FHSA presents a chronic hazard. All default assumptions contained in the guide-lines on hazard and risk determination are subject to replacement when alter-natives which are supported by appro-priate data become available. The fol-lowing are brief summaries of more ex-

tensive discussions contained in the guidelines. Thus, the guidelines should be consulted in conjunction with these summaries. Copies of the guidelines may be obtained from the Office of Compliance and Enforcement, Con-sumer Product Safety Commission, Washington, DC 20207. (In addition to the chronic hazards discussed below, issues relating to the chronic hazard of sensitization are discussed in 16 CFR 1500.3(c)(5).)

(a) Carcinogenicity. Substances are toxic by reason of their potential car-cinogenicity in humans when they are known or probable human carcinogenic substances as defined below. Sub-stances that are possible human car-cinogenic substances or for which there is no evidence of carcinogenic effect under the following categories lack sufficient evidence to be considered toxic by virtue of their potential car-cinogenicity.

(1) Known Human carcinogenic Sub-stances (‘‘sufficient evidence’’ in hu-mans). Substances are toxic by reason of their carcinogenicity when they meet the ‘‘sufficient evidence’’ criteria of carcinogenicity from studies in hu-mans, which require that a causal rela-tionship between exposure to an agent and cancer be established. This cat-egory is similar to the Environmental Protection Agency’s (EPA) Group A, the International Agency for Research on Cancer’s (IARC) Group 1, or the American National Standards Insti-tute’s (ANSI) Category 1. A causal rela-tionship is established if one or more epidemiological investigations that meet the following criteria show an as-sociation between cancer and exposure to the agent.

(i) No identified bias that can ac-count for the observed association has been found on evaluation of the evi-dence.

(ii) All possible confounding factors which could account for the observed association can be ruled out with rea-sonable confidence.

(iii) Based on statistical analysis, the association has been shown unlikely to be due to chance.

(2) Probable Human Carcinogenic Sub-stances. Substances are also toxic by reason of their probable carcino-genicity when they meet the ‘‘limited


518

16 CFR Ch. II (1–1–10 Edition) § 1500.135

evidence’’ criteria of carcinogenicity in humans or the ‘‘sufficient evidence’’ criteria of carcinogenicity in animals described below. This category is simi-lar to EPA’s Group B, IARC’s Group 2, or ANSI’s Categories 2 and 3. Evidence derived from animal studies that has been shown not to be relevant to hu-mans is not included. For example, such evidence would result when there was an identified mechanism of action for a chemical that causes cancer in animals that has been shown not to apply to the human situation. It is rea-sonable, for practical purposes, to re-gard an agent for which there is ‘‘suffi-cient’’ evidence of carcinogenicity in animals as if it presented a carcino-genic risk to humans.

(i) ‘‘Limited evidence’’ of carcino-genicity in humans. The evidence is con-sidered limited for establishing a caus-al relationship between exposure to the agent and cancer when a causal inter-pretation is credible, but chance, bias, or other confounding factors could not be ruled out with reasonable con-fidence.

(ii) ‘‘Sufficient evidence’’ of carcino-genicity in animals. Sufficient evidence of carcinogenicity requires that the substance has been tested in well-de-signed and -conducted studies (e.g., as conducted by National Toxicology Pro-gram (NTP), or consistent with the Of-fice of Science Technology Assessment and Policy (OSTP) guidelines) and has been found to elicit a statistically sig-nificant (p <0.05) exposure-related in-crease in the incidence of malignant tumors, combined malignant and be-nign tumors, or benign tumors if there is an indication of the ability of such benign tumors to progress to malig-nancy:

(A) In one or both sexes of multiple species, strains, or sites of independent origin; or experiments using different routes of administration or dose levels; or

(B) To an unusual degree in a single experiment (one species/strain/sex) with regard to unusual tumor type, un-usual tumor site, or early age at onset of the tumor. The presence of positive effects in short-term tests, dose-response effects data, or structure-activity relationship are considered additional evidence.

(3) Possible Human Carcinogenic Sub-stance (‘‘limited evidence’’ animal car-cinogen). In the absence of ‘‘sufficient’’ or ‘‘limited’’ human data, agents with ‘‘limited’’ evidence of carcinogenicity from animal studies fall into this cat-egory. Such substances, and those that do not fall into any other group, are not considered ‘‘toxic.’’ This does not imply that the substances are or are not carcinogens, only that the evidence is too uncertain to provide for a deter-mination. This category is similar to EPA’s Group C, IARC’s Group 3, or ANSI’s category 4.

(b) Neurotoxicity. Substances are toxic by reason of their potential neurotoxicity in humans when they meet the ‘‘sufficient evidence’’ or ‘‘limited evidence’’ criteria of neurotoxicity in humans, or when they meet the ‘‘sufficient evidence’’ criteria of neurotoxicity in animals.

(1) Known Neurotoxic Substances (‘‘sufficient evidence in humans’’). Sub-stances are toxic by reason of their neurotoxicity and are considered ‘‘known neurotoxic substances’’ when they meet the ‘‘sufficient evidence’’ criteria of neurotoxicity derived from studies in humans which require that a causal association between exposure to an agent and neurotoxicity be estab-lished with a reasonable degree of cer-tainty. Substances in this category meet the definition of ‘‘neurotoxic’’ as stated above. ‘‘Sufficient evidence,’’ derived from human studies, for a caus-al association between exposure to a chemical and neurotoxicity is consid-ered to exist if the studies meet the fol-lowing criteria.

(i) A consistent pattern of neuro-logical dysfunction is observed.

(ii) The adverse effects/lesions ac-count for the neurobehavioral dysfunc-tion with reasonable certainty.

(iii) All identifiable bias and con-founding factors are reasonably dis-counted after consideration.

(iv) The association has been shown unlikely to be due to chance, based on statistical analysis.

(2) Probable Neurotoxic Substances. Substances are also toxic by reason of their probable neurotoxicity when they meet the ‘‘limited evidence’’ criteria of neurotoxicity in humans, or the ‘‘suf-ficient evidence’’ criteria derived from


519


animal studies. Evidence derived from animal studies that has been shown not to be relevant to humans is not in-cluded. Such evidence would result, for example, when there was an identified mechanism of action for a chemical that causes neurotoxicity in animals that has been shown not to apply to the human situation.

(i) ‘‘Limited evidence’’ of neurotoxicity in humans. The evidence derived from human studies is considered limited for neurotoxicity when the evidence is less than convincing, i.e., one of the cri-teria of ‘‘sufficient evidence’’ of neurotoxicity for establishing a causal association between exposure to the agent and neurotoxicity is not met, leaving some uncertainties in estab-lishing a causal association.

(ii) ‘‘Sufficient evidence’’ of neurotoxicity in animals. Sufficient evi-dence of neurotoxicity derived from animal studies for a causal association between exposure to a chemical and neurotoxicity requires that:

(A) The substance has been tested in well-designed and -conducted studies (e.g., NTP’s neurobehavioral battery, or conforming to EPA’s neurotoxicity test guidelines); and

(B) The substance has been found to elicit a statistically significant (p <0.05) increase in any neurotoxic effect in one or both sexes of multiple spe-cies, strains, or experiments using dif-ferent routes of administration and dose-levels.

(3) Possible Neurotoxic Substances. ‘‘Possible neurotoxic substances’’ are the substances which meet the ‘‘lim-ited evidence’’ criteria of neurotoxicity evidence derived from animal studies in the absence of human data, or in the presence of inadequate human data, or data which do not fall into any other group. Substances in this category are not considered ‘‘toxic.’’

(c) Developmental and Reproductive Toxicity—(1) Definitions of ‘‘Sufficient’’ and ‘‘Limited’’ Evidence. The following definitions apply to all categories stat-ed below.

(i) ‘‘Sufficient evidence’’ from human studies for a causal association be-tween human exposure and the subse-quent occurrence of developmental or reproductive toxicity is considered to

exist if the studies meet the following criteria:

(A) No identified bias that can ac-count for the observed association has been found on evaluation of the evi-dence.

(B) All possible confounding factors which could account for the observed association can be ruled out with rea-sonable confidence.

(C) Based on statistical analysis, the association has been shown unlikely to be due to chance.

(ii) ‘‘Limited evidence’’ from human studies exists when the human epide-miology meets all but one of the cri-teria for ‘‘sufficient evidence’’; i.e., the statistical evidence is borderline as op-posed to clear-cut, there is a source of bias, or there are confounding factors that have not been and cannot be ac-counted for.

(iii) ‘‘Sufficient evidence’’ from ani-mal studies exists when

(A) Obtained from a good quality ani-mal study; and

(B) The substance has been found to elicit a statistically significant (p<0.05) treatment-related increase in multiple endpoints in a single species/strain, or in the incidence of a single endpoint at multiple dose levels or with multiple routes of administration in a single species/strain, or increase in the inci-dence of a single endpoint in multiple species/strains/ experiments.

(iv) ‘‘Limited evidence’’ from animal studies exists when:

(A) Obtained from a good quality study and there is a statistically sig-nificant (p<0.05) treatment-related in-crease in the incidence of a single end-point in a single species/strain/experi-ment at a single dose level adminis-tered through only one route and such evidence otherwise does not meet the criteria for ‘‘sufficient evidence’’; or

(B) The evidence is derived from studies which can be interpreted to show positive effects but have some qualitative or quantitative limitations with respect to experimental proce-dures (e.g., doses, exposure, follow-up, number of animals/group, reporting of the data, etc.) which would prevent classification of the evidence in the group of ‘‘sufficient evidence.’’


520

16 CFR Ch. II (1–1–10 Edition) § 1500.135

(2) Developmental Toxicants. Sub-stances are toxic by reason of their po-tential developmental or reproductive toxicity when they meet the ‘‘suffi-cient evidence’’ or ‘‘limited evidence’’ criteria of developmental or reproduc-tive toxicity in humans, or when they meet the ‘‘sufficient evidence’’ criteria of developmental or reproductive tox-icity in animals. The Food and Drug Administration (FDA) and the Euro-pean Economic Community (EEC) have developed categories for teratogens but not other developmental toxicants. The teratogen guidelines limit the informa-tion only to structural birth defects and do not include other hazards of de-velopmental toxicity such as embryonal death, fetal death, or func-tional deficiencies which are also im-portant in assessing the overall tox-icity of a substance when administered during pregnancy. Recently, EPA has proposed a system for classifying de-velopmental toxicity. The Occupa-tional Safety and Health Administra-tion (OSHA) has not yet developed any classification for developmental tox-icity. The commission has established the following categories for determina-tion of developmental toxicity accord-ing to the available evidence.

(i) Known Human Developmental Toxi-cant (‘‘sufficient evidence in humans’’). A substance is considered a ‘‘known human developmental toxicant’’ if there is ‘‘sufficient’’ human evidence to establish a causal association between human exposure and the subsequent oc-currence of developmental toxicity manifested by death of the conceptus (embryo or fetus), or structural or functional birth defects. This category (Human Developmental Toxicant) is comparable to category 1 of the EEC and categories D and X of FDA, except that these guidelines are limited to teratogens. This category is also com-parable to the category ‘‘definitive evi-dence for human developmental tox-icity’’ proposed by EPA.

(ii) Probable Human Developmental Toxicant. A substance is considered a ‘‘probable human developmental toxi-cant’’ if there is ‘‘limited’’ human evi-dence or ‘‘sufficient’’ animal evidence to establish a causal association be-tween human exposure and subsequent occurrence of developmental toxicity.

This group (Probable Human Develop-mental Toxicant) is comparable to the category ‘‘adequate evidence for human developmental toxicity’’ pro-posed by EPA. This category is also comparable to category 2 of the EEC and category A1 of FDA, except that these guidelines are limited to teratogens.

(iii) Possible Human Developmental Toxicant. A substance is considered a ‘‘possible human developmental toxi-cant’’ if there is ‘‘limited’’ animal evi-dence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal asso-ciation between human exposure and subsequent occurrence of develop-mental toxicity. EEC, FDA, and EPA have not developed a category com-parable to this group. The Commission believes that data from well planned animal studies are important to con-sider even though they may provide only limited evidence of developmental toxicity.

(3) Male Reproductive Toxicants. Male reproductive toxicants can be grouped into the following different categories based on evidence obtained from human or animal studies.

(i) Known Human Male Reproductive Toxicant. A substance is considered a ‘‘known human male reproductive toxi-cant’’ if there is ‘‘sufficient’’ human evidence to establish a causal associa-tion between human exposure and the adverse effects on male reproductive main endpoints which are mating abil-ity, fertility, and prenatal and post-natal development of the conceptus. This category is comparable to the one termed ‘‘Known Positive’’ in the EPA guidelines on male reproductive risk assessment.

(ii) Probable Human Male Reproductive Toxicant. A substance is considered a ‘‘probable human male reproductive toxicant’’ if there is ‘‘limited’’ human evidence or ‘‘sufficient’’ animal evi-dence to establish a causal association between human exposure and the ad-verse effects on male reproductive main endpoints. This category is com-parable to the one termed ‘‘Probable Positive’’ in the EPA guidelines on male reproductive risk assessment. However, the EPA category is based


521


only on sufficient animal evidence. CPSC believes that limited human evi-dence is also sufficient for a chemical to be placed in this category.

(iii) Possible Human Male Reproductive Toxicant. A substance is considered a ‘‘possible human male reproductive toxicant’’ if there is limited animal evidence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal association between human exposure and adverse effects on male reproduc-tive main endpoints. This category is comparable to the one termed ‘‘Pos-sible Positive A’’ in the EPA guidelines on male reproductive risk assessment. EPA proposes to use either limited human or limited animal evidence data to classify a toxicant as a ‘‘Possible Positive A’’ toxicant. As described above, CPSC would elevate limited human evidence to the category ‘‘Probable Human Male Reproductive Toxicant.’’

(4) Female Reproductive Toxicants. Fe-male reproductive toxicants can be grouped into the following different categories based on evidence obtained from human or animal studies. EPA has proposed guidelines for assessing female reproductive risk but has not yet proposed a specific system for cat-egorization of female reproductive toxicants.

(i) Known Human Female Reproductive Toxicant. A substance is considered a ‘‘known human female reproductive toxicant’’ if there is ‘‘sufficient’’ human evidence to establish a causal association between human exposure and adverse effects on female reproduc-tive function such as mating ability, fertility, and prenatal and postnatal development of the conceptus.

(ii) Probable Human Female Reproduc-tive Toxicant. A substance is considered a ‘‘probable human female reproduc-tive toxicant’’ if there is ‘‘limited’’ human evidence or ‘‘sufficient’’ animal evidence to establish a causal associa-tion between human exposure and ad-verse effects on female reproductive function.

(iii) Possible Human Female Reproduc-tive Toxicant. A substance is considered a ‘‘possible human female reproductive toxicant’’ if there is ‘‘limited’’ animal

evidence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal association between human exposure and adverse effects on female reproduc-tive function.

(d) Other Subjects Related to the Deter-mination that a Substance is Toxic. Under the FHSA, for a toxic substance to be considered hazardous, it must not only have the potential to be hazardous but there must also be the potential that persons are exposed to the sub-stance, that the substance can enter the body, and that there is a signifi-cant risk of an adverse health effect as-sociated with the customary handling and use of the substance. Under these guidelines, existence of an adverse health effect means that such exposure is above the ‘‘acceptable daily intake’’ (‘‘ADI’’). The ADI is based on the risks posed by the substance, and whether they are acceptable under the FHSA. This section addresses those issues by providing guidelines concerning assess-ment of exposure, assessment of bio-availability, determination of accept-able risks and the ADI to children and adults, and assessment of risk.

(1) Assessment of Exposure. An expo-sure assessment may comprise a single exposure scenario or a distribution of exposures. Reasonably foreseeable use, as well as accidental exposure, should be taken into consideration when de-signing exposure studies. The following guidelines should be used in the assess-ment of exposure.

(i) Inhalation. Inhalation studies to assess exposure should be reliable stud-ies using direct monitoring of popu-lations, predictions of exposure through modeling, or surrogate data.

(A) Direct Monitoring. Populations to be monitored should be selected ran-domly to be representative of the gen-eral population, unless the exposure of a particular subset population is the desired goal of the assessment. The monitoring technique should be appro-priate for the health effect of interest.

(B) Modeling. Predictions of exposure to a chemical using mathematical models can be based on physical and chemical principles, such as mass bal-ance principles. Mass balance models should consider the source strength of


522

16 CFR Ch. II (1–1–10 Edition) § 1500.135

the product of interest, housing char-acteristics, and ambient conditions likely to be encountered by the studied population.

(C) Surrogate Data. Surrogate data should only be used when data con-cerning the chemical of interest are sparse or unavailable and when there is a reasonable assurance that the surro-gate data will accurately represent the chemical of interest.

(ii) Oral Ingestion. Oral ingestion studies may involve direct monitoring of sources of chemicals as well as lab-oratory simulations. The estimation of exposure from ingestion of chemicals present in consumer products is pre-dicted based upon estimates of use of the product and absorption of the chemical from the gastrointestinal tract. The following criteria should be established for laboratory simulations to estimate exposure:

(A) A simulant or range of simulants should be carefully selected to mimic the possible range of conditions which occur in humans, such as full and empty stomachs, or various saliva compositions at different times of the day.

(B) The mechanical action to which a product is submitted must be chosen to represent some range of realistic condi-tions to which a human may subject the product.

(iii) Dermal Exposure. (A) Dermal ex-posure involves estimating the amount of substance contacting the skin. This may involve experiments measuring the amount of material leached from a product contacting a liquid layer which interfaces with the skin, or the amount of substance which migrates from a product (in solid or liquid form) which is in contact with the skin.

(B) Parameters to be considered in-clude: Surface area of the skin con-tacted, duration of contact, frequency of contact, and thickness of a liquid interfacial layer.

(2) Assessment of Bioavailability. (i) The need to consider bioavailability in estimating the risk from use of a prod-uct containing a toxic substance only arises when it is anticipated that the absorption characteristics of a sub-stance to which there is human expo-sure will differ from those characteris-tics for the substance tested in the

studies used to define the dose-response relationship.

(ii) In determining the need to assess bioavailability, the factors to be exam-ined include:

(A) The physical or chemical form of the substance,

(B) The route of exposure (inhalation, ingestion, or through the skin),

(C) The presence of other constitu-ents in the product which interfere with or alter absorption of the toxic substance, and

(D) Dose. (3) Assessment of Risk. This section on

quantitative risk assessment applies to estimates of risk for substances that are toxic by reason of their carcino-genicity.

(i) Generally, the study leading to the highest risk should be used in the risk assessment; however, other factors may influence the choice of study.

(ii) Risk should be based on the max-imum likelihood estimate from a multistage model (such as Global83 or later version) unless the maximum likelihood estimate is not linear at low dose, in which case the 95% upper con-fidence limit on risk should be used.

(iii) For systemic carcinogens, if esti-mates of human risk are made based on animal data, a factor derived from di-viding the assumed human weight (70 kg) by the average animal weight dur-ing the study and taking that to the 1⁄3 power should be used. There is the pos-sibility that this factor may be changed, using the 1⁄4 power instead of the 1⁄3 power, as part of a unified Fed-eral regulatory approach. If such an ap-proach is adopted, it will apply here.

(iv) When dose is expressed as parts per million, and the carcinogen acts at the site of contact, humans and ani-mals exposed to the same amount for the same proportion of lifetime should be assumed to be equally sensitive.

(v) If no experimental study having the same route of exposure as that an-ticipated for human use of a substance is available, a study by another route of exposure may be used. Pharmaco-kinetic methods may be used if suffi-cient data are available.

(vi) When exposure scenarios are dif-ferent from those used in the under-lying study upon which estimates of risk are based, proportionality should


523


be applied. If pharmacokinetic methods are used to adjust for risks at high versus low exposure levels, level-time measures should not be combined with-out taking the non-linearity into ac-count.

(4) Acceptable Risks—(i) ADI for Car-cinogens. The maximum acceptable daily intake (‘‘ADI’’) is that exposure of a toxic (by virtue of its carcino-genicity) substance that is estimated to lead to a lifetime excess risk of one in a million. Exposure refers to the an-ticipated exposure from normal life-time use of the product, including use as a child as well as use as an adult.

(ii) ADI for Neurotoxicological and De-velopmental/Reproductive Agents. Due to the difficulties in using a numerical risk assessment method to determine risk for neurotoxicological or develop-mental/reproductive toxicants, the Commission is using a safety factor ap-proach, as explained below.

(A) Human Data. If the hazard is ascertained from human data, a safety factor of ten will be applied to the low-est No Observed Effect Level (‘‘NOEL’’) seen among the relevant studies. If no NOEL can be determined, a safety fac-tor of 100 will be applied to the Lowest Observed Effect Level (‘‘LOEL’’). Both the NOEL and LOEL are defined in terms of daily dose level.

(B) Animal Data. If the hazard is ascertained from animal data, a safety factor of one hundred will be applied to the lowest NOEL. If no NOEL can be determined, a safety factor of one thousand will be applied to the lowest LOEL. Both the NOEL and LOEL are defined in terms of daily dose level.

[57 FR 46665, Oct. 9, 1992]

§ 1500.210 Responsibility. The provisions of these regulations

(16 CFR subchapter C of chapter II) with respect to the doing of any act shall be applicable also to the causing of such act to be done.

§ 1500.211 Guaranty. In the case of the giving of a guar-

anty or undertaking referred to in sec-tion 5(b)(2) of the act, each person sign-ing such guaranty or undertaking, or causing it to be signed, shall be consid-ered to have given it. Each person causing a guaranty or undertaking to

be false is chargeable with violations of section 4(d) of the act.

§ 1500.212 Definition of guaranty; sug-gested forms.

(a) A guaranty or undertaking re-ferred to in section 5(b)(2) of the act may be:

(1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment of delivery; or

(2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or deliv-ered, or caused to be shipped or deliv-ered, by the person who gives the guar-anty of undertaking.

(b) The following are suggested forms of guaranty or undertaking referred to in section 5(b)(2) of the act. (1) Limited form for use on invoice or bill of sale.

(Name of person giving the guaranty or un-dertaking)

hereby guarantees that no article listed herein is misbranded within the meaning of the Federal Hazardous Substances Act. (Signature and post-office address of person

giving the guaranty or undertaking)

(2) General and continuing forms.

The article comprising each shipment or other delivery hereafter made by lllll

(Name of person giving the guaranty or undertaking)

to, or on the order of llllllllll

(Name and post-office address of person to whom the guaranty or undertaking is given)

is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not misbranded within the meaning of the Federal Hazardous Substances Act. (Signature and post-office address of person giving the guaranty or undertaking)

(c) The application of a guaranty or undertaking referred to in section 5(b)(2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes mis-branded within the meaning of the act.


524

16 CFR Ch. II (1–1–10 Edition) § 1500.213

1 This guidance is not a rule. It is intended to highlight certain obligations under the Federal Hazardous Substances Act. Compa-nies should read that Act and the accom-panying regulations in this part for more de-tailed information.

§ 1500.213 Presentation of views under section 7 of the act.

(a) Presentation of views under sec-tion 7 of the act shall be private and in-formal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or under-taking referred to in section 5(b)(2) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views.

(b) Upon request, reasonably made, by the person to whom a notice ap-pointing a time and place for the pres-entation of views under section 7 of the act has been given, or by his represent-ative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall be ad-dressed to the office of the Consumer Product Safety Commission that issued the notice.

§ 1500.214 Examinations and investiga-tions; samples.

When any officer or employee of the Commission collects a sample of a haz-ardous substance for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Com-mission indicating that the shipment or other lot of the article from which such sample was collected was intro-duced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory not organized with a legislative body. Only samples so designated by an offi-cer or employee of the Commission shall be considered to be official sam-ples:

(a) For the purpose of determining whether or not a sample is collected for analysis, the term ‘‘analysis’’ includes examinations and tests.

(b) The owner of a hazardous sub-stance of which an official sample is collected is the person who owns the

shipment or other lot of the article from which the sample is collected.

§ 1500.230 Guidance for lead (Pb) in consumer products.

(a) Summary. (1) The U.S. Consumer Product Safety Commission issues this guidance to manufacturers, importers, distributors, and retailers to protect children from hazardous exposure to lead in consumer products. 1 The Com-mission identifies the major factors that it considers when evaluating prod-ucts that contain lead, and informs the public of its experience with products that have exposed children to poten-tially hazardous amounts of lead.

(2) To reduce the risk of hazardous exposure to lead, the Commission re-quests manufacturers to eliminate the use of lead that may be accessible to children from products used in or around households, schools, or in recre-ation. The Commission also rec-ommends that, before purchasing prod-ucts for resale, importers, distributors, and retailers obtain assurances from manufacturers that those products do not contain lead that may be accessible to children.

(b) Hazard. Young children are most commonly exposed to lead in consumer products from the direct mouthing of objects, or from handling such objects and subsequent hand-to-mouth activ-ity. The specific type and frequency of behavior that a child exposed to a prod-uct will exhibit depends on the age of the child and the characteristics and pattern of use of the product. The ad-verse health effects of lead poisoning in children are well-documented and may have long-lasting or permanent con-sequences. These effects include neuro-logical damage, delayed mental and physical development, attention and learning deficiencies, and hearing prob-lems. Because lead accumulates in the body, even exposures to small amounts of lead can contribute to the overall level of lead in the blood and to the


525


subsequent risk of adverse health ef-fects. Therefore, any unnecessary expo-sure of children to lead should be avoided. The scientific community gen-erally recognizes a level of 10 micrograms of lead per deciliter of blood as a threshold level of concern with respect to lead poisoning. To avoid exceeding that level, young chil-dren should not chronically ingest more than 15 micrograms of lead per day from consumer products.

(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261(f)(1), household products that expose children to hazardous quantities of lead under reasonably foreseeable conditions of handling or use are ‘‘hazardous substances.’’ A household product that is not intended for children but which creates such a risk of injury because it contains lead requires precautionary labeling under the Act. 15 U.S.C. 1261(p). A toy or other article intended for use by chil-dren which contains a hazardous amount of lead that is accessible for children to ingest is a banned haz-ardous substance. 15 U.S.C. 1261(q)(1)(B). In evaluating the poten-tial hazard associated with products that contain lead, the Commission staff considers these major factors on a case-by-case basis: the total amount of lead contained in a product, the bio-availability of the lead, the accessi-bility of the lead to children, the age and foreseeable behavior of the chil-dren exposed to the product, the fore-seeable duration of the exposure, and the marketing, patterns of use, and life cycle of the product.

(2) Paint and similar surface coatings containing lead have historically been the most commonly-recognized sources of lead poisoning among the products within the Commission’s jurisdiction. The Commission has, by regulation, banned paint and other similar surface coatings that contain more than 0.06% lead (‘‘lead-containing paint’’), toys and other articles intended for use by children that bear lead-containing paint, and furniture articles for con-sumer use that bear lead-containing paint. 16 CFR Part 1303. In recent years, however, the Commission staff has identified a number of disparate products—some intended for use by

children and others simply used in or around the household or in recre-ation—that presented a risk of lead poisoning from sources other than paint. These products included vinyl miniblinds, crayons, figurines used as game pieces, and children’s jewelry.

(3) In several of these cases, the staff’s determination that the products presented a risk of lead poisoning re-sulted in recalls or in the replacement of those products with substitutes, in addition to an agreement to dis-continue the use of lead in future pro-duction. The Commission believes that, had the manufacturers of these lead- containing products acted with pru-dence and foresight before introducing the products into commerce, they would not have used lead at all. This in turn would have eliminated both the risk to young children and the costs and other consequences associated with the corrective actions.

(4) The Commission urges manufac-turers to eliminate lead in consumer products to avoid similar occurrences in the future. However, to avoid the possibility of a Commission enforce-ment action, a manufacturer who be-lieves it necessary to use lead in a con-sumer product should perform the req-uisite analysis before distribution to determine whether the exposure to lead causes the product to be a ‘‘hazardous substance.’’ If the product is a haz-ardous substance and is also a chil-dren’s product, it is banned. If it is a hazardous household substance but is not intended for use by children, it re-quires precautionary labeling. This same type of analysis also should be performed on materials substituted for lead.

(5) The Commission also notes that, under the FHSA, any firm that pur-chases a product for resale is respon-sible for determining whether that product contains lead and, if so, wheth-er it is a ‘‘hazardous substance.’’ The Commission, therefore, recommends that, prior to the acquisition or dis-tribution of such products, importers, distributors, and retailers obtain infor-mation and data, such as analyses of chemical composition or accessibility, relevant to this determination from


526

16 CFR Ch. II (1–1–10 Edition) § 1500.231

1 This guidance is not a rule. It is intended to highlight certain obligations under the Federal Hazardous Substances Act. Compa-nies should read that Act and the accom-panying regulations in this part for more de-tailed information.

manufacturers, or have such evalua-tions conducted themselves.

[63 FR 70649, Dec. 22, 1998]

§ 1500.231 Guidance for hazardous liq-uid chemicals in children’s prod-ucts.

(a) Summary. The U.S. Consumer Product Safety Commission issues this guidance to manufacturers, importers, distributors, and retailers to protect children from exposure to hazardous chemicals found in liquid-filled chil-dren’s products, such as rolling balls, bubble watches, necklaces, pens, paper-weights, keychains, liquid timers, and mazes. 1 The Commission identifies the major factors that it considers when evaluating liquid-filled children’s prod-ucts that contain hazardous chemicals, and informs the public of its experience with exposure to these hazardous chemicals to children. To reduce the risk of exposure to hazardous chemi-cals, such as mercury, ethylene glycol, diethylene glycol, methanol, meth-ylene chloride, petroleum distillates, toluene, xylene, and related chemicals, the Commission requests manufactur-ers to eliminate the use of such chemi-cals in children’s products. The Com-mission also recommends that, before purchasing products for resale, import-ers, distributors, and retailers obtain assurances from manufacturers that liquid-filled children’s products do not contain hazardous liquid chemicals.

(b) Hazard. During reasonably fore-seeable handling or use of liquid-filled children’s products, hazardous chemi-cals may become accessible to young children in a manner that places chil-dren at risk. Young children are ex-posed to the chemicals from directly mouthing them or from handling such objects and subsequent hand-to-mouth or hand-to-eye activity. The specific type and frequency of behavior that a child exposed to a product will exhibit depends on the age of the child and the characteristics and pattern of use of the product. The adverse health effects

of these chemicals to children include chemical poisoning from ingestion of the chemicals, pneumonia from aspira-tion of the chemicals into the lungs, and skin and eye irritation from expo-sure to the chemicals. The chemicals may also be combustible.

(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA), products that are toxic or irritants and that may cause substantial injury or illness under reasonably foreseeable conditions of handling or use, including reasonably foreseeable ingestion by children, are ‘‘hazardous substances.’’ 15 U.S.C. 1261(f)(1). A product that is not intended for children, but that cre-ates a risk of substantial injury or ill-ness because it contains hazardous chemicals, requires precautionary la-beling under the Act. 15 U.S.C. 1261(p). A toy or other article intended for use by children that contains an accessible and harmful amount of a hazardous chemical is banned. 15 U.S.C. 1261(q)(1)(A). In evaluating the poten-tial hazard associated with children’s products that contain hazardous chemicals, the Commission’s staff con-siders certain factors on a case-by-case basis, including: the total amount of the hazardous chemical in a product, the accessibility of the hazardous chemicals to children, the risk pre-sented by that accessibility, the age and foreseeable behavior of the chil-dren exposed to the product, and the marketing, patterns of use, and life cycle of the product.

(2) The Commission’s staff has identi-fied a number of liquid-filled children’s products, such as rolling balls, bubble watches, necklaces, pens, paper-weights, maze toys, liquid timers, and keychains, that contain hazardous chemicals. In several of these cases, the staff determined that these prod-ucts violated the FHSA because they presented a risk of chemical poisoning and/or chemical pneumonia from aspi-ration. This determination resulted in recalls or in the replacement of those products with substitutes, as well as in agreements with the manufacturers to discontinue the use of hazardous chemicals in liquid-filled children’s products in future production. The Commission believes that these haz-ardous substances pose a risk to young


527


children and, consequently, manufac-turers should not have included them in the product design or manufacturing process.

(3) Therefore, the Commission con-siders the use of hazardous chemicals in children’s products such as those de-scribed above to be ill-advised and en-courages manufacturers to avoid using them in such products. Further, the Commission recommends that, before purchasing such products for resale, importers, distributors, and retailers obtain assurances from the manufac-turers that liquid-filled children’s products do not contain hazardous liq-uid chemicals.

[63 FR 70648, Dec. 22, 1998]

IMPORTS

§ 1500.265 Imports; definitions.

For the purposes of the regulations prescribed under section 14 of the act:

(a) The term owner or consignee means the person who has the rights of a consignee under the provisions of the Tariff Act of 1930 (secs. 483, 484, 485, 46 Stat. 721 as amended; 19 U.S.C. 1483, 1484, 1485).

(b) The term area office director means the director of the area office of the Consumer Product Safety Commission having jurisdiction over the port of entry through which a hazardous sub-stance is imported or offered for im-port, or such officer of the area office as he may designate to act in his behalf in administering and enforcing the pro-visions of section 14 of the act.

§ 1500.266 Notice of sampling.

When a sample of a hazardous sub-stance offered for import has been re-quested by the director of the area of-fice, the collector of customs having jurisdiction over the hazardous sub-stance shall give to the owner or con-signee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or con-signee shall hold such hazardous sub-stance and not distribute it until fur-ther notice from the area office direc-tor or the collector of customs of the results of examination of the sample.

§ 1500.267 Payment for samples. The Consumer Product Safety Com-

mission will pay for all import samples that are found to be in compliance with the requirements of the act. Billing for reimbursement should be made by the owner or consignee to the Commission area office headquarters in the terri-tory of which the shipment was offered for import. Payment for samples will not be made if the hazardous substance is found to be in violation of the act, even though subsequently brought into compliance under the terms of an au-thorization to bring the article into compliance.

§ 1500.268 Hearing. (a) If it appears that the hazardous

substance may be subject to refusal of admission, the area office director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request, giving reasonable grounds therefor, such time and place may be changed. Such testi-mony shall be confined to matters rel-evant to the admissibility of the haz-ardous substance, and may be intro-duced orally or in writing.

(b) If such owner or consignee sub-mits or indicates his intention to sub-mit an application for authorization to relabel or perform other action to bring the hazardous substance into compliance with the act, such testi-mony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the area office director shall specify a time limit, reasonable in the light of the circumstances, for filing such application.

§ 1500.269 Application for authoriza-tion.

Application for authorization to relabel or perform other action to bring the hazardous substance into compliance with the act may be filed only by the owner or consignee and shall:

(a) Contain detailed proposals for bringing the article into compliance with the act.


528

16 CFR Ch. II (1–1–10 Edition) § 1500.270

(b) Specify the time and place where such operations will be carried out and the approximate time for their comple-tion.

§ 1500.270 Granting of authorization. (a) When authorization contemplated

by § 1500.269 is granted, the area office director shall notify the applicant in writing, specifying:

(1) The procedure to be followed: (2) That the operations are to be car-

ried out under the supervision of an of-ficer of the Consumer Product Safety Commission or the Bureau of Customs, as the case may be;

(3) A time limit, reasonable in the light of the circumstances, for comple-tion of the operations; and

(4) Such other conditions as are nec-essary to maintain adequate super-vision and control over the article.

(b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the area office direc-tor may grant such additional time as he deems necessary.

(c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the area office director.

(d) If ownership of a hazardous sub-stance covered by an authorization changes before the operations specified in the authorization have been com-pleted, the original owner will be held responsible, unless the new owner has executed a bond and obtained a new au-thorization. Any authorization granted under this section shall supersede and nullify any previously granted author-ization with respect to the article.

§ 1500.271 Bonds. (a) The bonds required under section

14(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the re-delivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the hazardous substance into compliance with the act in such manner as is pre-

scribed for such bond in the customs regulations in force on the date of re-quest for authorization. The bond shall be filed with the collector of customs.

(b) The collector of customs may can-cel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and condi-tions as shall be deemed appropriate under the law and in view of the cir-cumstances, but the collector shall not act under this regulation in any case unless the area office director is in full agreement with the action.

§ 1500.272 Costs chargeable in connec-tion with relabeling and recondi-tioning inadmissible imports.

The cost of supervising the relabeling or other action necessary in connection with an import of a hazardous sub-stance that fails to comply with the act shall be paid by the owner or con-signee who files an application request-ing such action and executes a bond, pursuant to section 14(b) of the act. The cost of such supervision shall in-clude, but not be restricted to, the fol-lowing:

(a) Travel expenses of the supervising officer.

(b) Per diem in lieu of subsistence of the supervising officer when away from his home station as provided by law.

(c) Services of the supervising officer, to be calculated at the rate of a GS 11, step 1 employee, except that such serv-ices performed by a customs officer and subject to the provisions of the Act of February 13, 1911, as amended (sec. 5, 36 Stat. 901 as amended; 19 U.S.C. 267), shall be calculated as provided in that Act.

(d) Services of the analyst, to be cal-culated at the rate of a GS 12, step 1 employee (which shall include the use of the chemical laboratories and equip-ment of the Consumer Product Safety Commission).

(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1 hour, and time after the first hour shall be computed in multiples of 1


529


hour, disregarding fractional parts less than one-half hour.

[38 FR 27012, Sept. 27, 1973, as amended at 57 FR 28605, June 26, 1992]

PART 1501—METHOD FOR IDENTI-FYING TOYS AND OTHER ARTI-CLES INTENDED FOR USE BY CHILDREN UNDER 3 YEARS OF AGE WHICH PRESENT CHOKING, ASPIRATION, OR INGESTION HAZARDS BECAUSE OF SMALL PARTS

Sec. 1501.1 Purpose. 1501.2 Scope. 1501.3 Exemptions. 1501.4 Size requirements and test procedure. 1501.5 Enforcement procedure.

AUTHORITY: Secs. 2(f)(1)(D), (q)(1)(A), (s), 3(e)(1), and 10; 74 Stat. 372, 374, 375 as amend-ed; 80 Stat. 1304–05, 83 Stat. 187–89 (15 U.S.C. 1261, 1262, 1269).

SOURCE: 44 FR 34903, June 15, 1979, unless otherwise noted.

§ 1501.1 Purpose. Section 1500.18(a)(9) of this chapter

classifies as a banned hazardous sub-stance any toy or other article in-tended for use by children under 3 years of age that presents a choking, aspiration, or ingestion hazard because of small parts. This part 1501 describes certain articles that are subject to § 1500.18(a)(9); lists certain articles that are specifically exempted; and provides a test method for determining whether an article is hazardous to children under 3 because it, or one of its compo-nents that can be detached or broken off during normal or reasonable fore-seeable use, is too small.

§ 1501.2 Scope. (a) This regulation (§ 1500.18(a)(9) and

the criteria described in § 1501.4 below) applies to all toys and other articles intended for use by children under 3 years (36 months) of age that are intro-duced into interstate commerce after the effective date. Such articles in-clude, but are not to limited to: squeeze toys; teethers; crib exercisers; crib gyms; crib mobiles; other toys or articles intended to be affixed to a crib, stroller, playpen, or baby carriage; pull

and push toys; pounding toys; blocks and stacking sets; bathtub, wading pool and sand toys; rocking, spring, and stick horses and other figures; chime and musical balls and carousels; jacks-in-the-box; stuffed, plush, and flocked animals and other figures; pre-school toys, games and puzzles in-tended for use by children under 3; riding toys intended for use by children under 3; infant and juvenile furniture articles which are intended for use by children under 3 such as cribs, play-pens, baby bouncers and walkers, strollers and carriages; dolls which are intended for use by children under 3 such as baby dolls, rag dolls, and bean bag dolls; toy cars, trucks, and other vehicles intended for use by children under 3. In addition, such articles in-clude any other toys or articles which are intended, marketed or labeled to be entrusted to or used by children under 3 years of age.

(b) In determining which toys and other articles are intended for use by children under 3 years (36 months) of age, for purposes of this regulation, the following factors are relevant: the manufacturer’s stated intent (such as on a label) if it is a reasonable one; the advertising, promotion, and marketing of the article; and whether the article is commonly recognized as being in-tended for children under 3.

(c) This regulation does not apply to toys or articles which are solely in-tended for use by children 3 years of age or older. In addition, it does not apply to all articles to which children under 3 years of age might have access simply because of presence in a house-hold. Certain articles which are specifi-cally exempted from this regulation are listed in § 1501.3 below.

§ 1501.3 Exemptions.

The following articles are exempt from this regulation (§§ 1500.18(a)(9) and 1501.4 below):

(a) Balloons; (b) Books and other articles made of

paper; (c) Writing materials such as cray-

ons, chalk, pencils, and pens; (d) Children’s clothing and acces-

sories, such as shoe lace holders and buttons;


SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACT … · 2017-10-02 · 419 SUBCHAPTER C—FEDERAL...

Documents

Transcript of SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACT … · 2017-10-02 · 419 SUBCHAPTER C—FEDERAL...